Patient Information

Patient Information

Patients: If you have a medical emergency call 911

It is our policy to provide technical information on prescription products to Pharmacists and Physicians only. Patients/consumers should contact their HealthCare Provider with any questions regarding prescription products and their uses.

Patient Information

Patient Information Sheets encourage patients to talk with their healthcare providers for further information. Patient Information Sheets also provide telephone and e-mail contact information for FDA’s Drug Information line to address specific questions. FDA continues to collect input on the usefulness of these consumer communications through feedback mechanisms, such as focus groups, surveys, and public meetings, and anticipates that these consumer communications will continue to evolve.
Source:  Drug Safety Information- FDA’s Communication to the Public.

Medication Guides

21 CFR section 208.1(c) authorizes FDA to require a Medication Guide if FDA determines one or more of the following circumstances exist:

(1) The drug product is one for which patient labeling could help prevent serious adverse effects.

(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product.

(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.  
 

Product Search

All brand names are registered trademarks of their respective owner(s).

Click on product to view details.

Product Type :
Pharmaceuticals
Alternative :
Xanax
NDC
51991-0704-01
Strength
0.25mg
Size(S)
100
Case Pack Units
48
NDC
51991-0704-05
Strength
0.25mg
Size(S)
500
Case Pack Units
24
NDC
51991-0704-10
Strength
0.25mg
Size(S)
1000
Case Pack Units
12
Imprint Code
B704
SCH
CIV
Rating
AB
Description

White to off white, oval, biconvex tablets with break line on one side and debossed B704 on the other side

NDC
51991-0705-01
Strength
0.5mg
Size(S)
100
Case Pack Units
48
NDC
51991-0705-05
Strength
0.5mg
Size(S)
500
Case Pack Units
24
NDC
51991-0705-10
Strength
0.5mg
Size(S)
1000
Case Pack Units
12
Imprint Code
B705
SCH
CIV
Rating
AB
Description

Light Orange to orange, oval, biconvex tablets with break line on one side and debossed B705 on the other side

NDC
51991-0706-01
Strength
1mg
Size(S)
100
Case Pack Units
48
NDC
51991-0706-05
Strength
1mg
Size(S)
500
Case Pack Units
24
NDC
51991-0706-10
Strength
1mg
Size(S)
1000
Case Pack Units
12
Imprint Code
B706
SCH
CIV
Rating
AB
Description

Light blue to blue, oval, biconvex tablets with break line on one side and debossed B706 on the other side

NDC
51991-0707-01
Strength
2mg
Size(S)
100
Case Pack Units
48
NDC
51991-0707-05
Strength
2mg
Size(S)
500
Case Pack Units
24
Imprint Code
B707
SCH
CIV
Rating
AB
Description

Light blue to blue, rectangle tablets with three breaklines on one side and two notches in between two breaklines, debossed B707 on the other side

Product Type :
Pharmaceuticals
Alternative :
ARIMIDEX
NDC
51991-0620-33
Strength
1mg
Size(S)
30
NDC
51991-0620-10
Strength
1mg
Size(S)
1000
Imprint Code
AN1
SCH
Rx
Rating
AB
Description

White, round, film-coated tablet, debossed with “AN” and “1” on one side

Product Type :
Pharmaceuticals
Alternative :
Fiorinal® w/Codeine Caps
NDC
51991-0074-01
Strength
30, 50, 325, 40
Size(S)
100
Case Pack Units
6
NDC
51991-0074-05
Strength
30, 50, 325, 40
Size(S)
500
Case Pack Units
12
Imprint Code
B 074
SCH
CIII
Rating
AB
Description

Capsule with blue opaque cap with yellow opaque body imprinted with "B 074" in black ink

Product Type :
Pharmaceuticals
Alternative :
Astelin
NDC
51991-0814-03
Strength
0.1%
Size(S)
30mL
Case Pack Units
24
SCH
Rx
Rating
AB
Description

200 Meter Spray. (Each Spray delivers 137mcg azelastine hydrochloride equivalent to 125mcg of azelastine base). HDPE bottle fitted with a metered-dose spray pump unit with a white safety clip and a white plastic dust cover.

Product Type :
Pharmaceuticals
Alternative :
Fioricet® w/Codeine Caps
NDC
51991-0073-01
Strength
50, 325, 40, 30
Size(S)
100
Case Pack Units
12
Imprint Code
B 073
SCH
CIII
Rating
AB
Description

Dark blue, opaque cap with a gray, opaque body, and body is imprinted with “B 073” in black ink

Product Type :
Pharmaceuticals
Alternative :
Onfi
NDC
51991-0900-01
Strength
10mg
Size(S)
100
Case Pack Units
24
Imprint Code
C 1
SCH
CIV
Rating
AB
Description

White to off-white, oval tablet with a functional score on one side and debossed C and 1 on the other side

NDC
51991-0901-01
Strength
20mg
Size(S)
100
Case Pack Units
24
Imprint Code
C 2
SCH
CIV
Rating
AB
Description

White to off-white, oval tablet with a functional score on one side and debossed C and 2 on the other side

Product Type :
Pharmaceuticals
Alternative :
Pristiq
NDC
51991-0006-33
Strength
25mg
Size(S)
30
Case Pack Units
24
Imprint Code
L634
SCH
Rx
Rating
AB
Description

tan colored, round, biconvex tablets, debossed with ‘L634’ on one side and plain on other side

NDC
51991-0311-33
Strength
50mg
Size(S)
30
NDC
51991-0311-90
Strength
50mg
Size(S)
90
Case Pack Units
24
NDC
51991-0311-10
Strength
50mg
Size(S)
1000
Case Pack Units
12
Imprint Code
L349
SCH
Rx
Rating
AB
Description

light pink colored, round, biconvex tablets, debossed with 'L349' on one side and plain on other side

NDC
51991-0312-33
Strength
100mg
Size(S)
30
Case Pack Units
24
NDC
51991-0312-90
Strength
100mg
Size(S)
90
Case Pack Units
24
NDC
51991-0312-10
Strength
100mg
Size(S)
1000
Case Pack Units
12
Imprint Code
L350
SCH
RX
Rating
AB
Description

dark brown to red colored, round, biconvex tablets, debossed with 'L350' on one side and plain on other side

Product Type :
Pharmaceuticals
Alternative :
Cymbalta
NDC
51991-0746-90
Strength
20 mg
Size(S)
90
Case Pack Units
24
NDC
51991-0746-05
Strength
20 mg
Size(S)
500
Case Pack Units
12
Imprint Code
B746
SCH
Rx
Rating
AB
Description

Opaque ochre capsules imprinted with "B" on the cap and "746" on the body.

NDC
51991-0747-90
Strength
30 mg
Size(S)
90
Case Pack Units
24
NDC
51991-0747-10
Strength
30 mg
Size(S)
1000
Case Pack Units
12
Imprint Code
B747
SCH
Rx
Rating
AB
Description

Opaque green (cap)/opaque white (body) capsules imprinted with "B" on the cap and "747" on the body.

NDC
51991-0748-90
Strength
60 mg
Size(S)
90
Case Pack Units
24
NDC
51991-0748-10
Strength
60 mg
Size(S)
1000
Case Pack Units
12
Imprint Code
B748
SCH
Rx
Rating
AB
Description

Opaque green (cap)/opaque ochre (body) capsules imprinted with "B" on the cap and "748" on the body.

NDC
51991-0750-33
Strength
40 mg
Size(S)
30
Imprint Code
B 750
SCH
Rx
Rating
AB
Description

Opaque blue (cap)/opaque orange (body) capsules imprinted with B on the cap and 750 on the body

Product Type :
Pharmaceuticals
Alternative :
Activella
NDC
51991-0474-28
Strength
1mg/0.5mg
Size(S)
28
Case Pack Units
20
Imprint Code
B 474
SCH
Rx
Rating
AB
Description

White, convex, coated tablets debossed with “B” on one side and “474” on the other side

NDC
51991-0623-28
Strength
0.5mg/0.1mg
Size(S)
28
Case Pack Units
20
Imprint Code
B 623
SCH
Rx
Rating
AB
Description

White, convex, coated tablet debossed with “B” on one side and “623” on the other side

Product Type :
Pharmaceuticals
Alternative :
Aromasin
NDC
51991-0005-33
Strength
25mg
Size(S)
30
Case Pack Units
24
Imprint Code
X 1
SCH
Rx
Rating
AB
Description

White colored, round, biconvex, film-coated tablets debossed with “X” on one side and “1” on other side

Product Type :
Medical Foods
Alternative :
Foltx (New Formula)
NDC
51991-0616-90
Size(S)
90
Imprint Code
LMF 1
Description

Round, beige colored tablet , debossed LMF on one side and 1 on the other side

 

 

Product Type :
Pharmaceuticals
Alternative :
Prevacid
NDC
51991-0771-33
Strength
15mg
Size(S)
30
NDC
51991-0771-10
Strength
15mg
Size(S)
1000
Imprint Code
NATCO 15
SCH
Rx
Rating
AB
Description

Capsule with green body and pink cap, printed NATCO on cap and 15 on body with white ink

NDC
51991-0772-90
Strength
30mg
Size(S)
90
NDC
51991-0772-05
Strength
30mg
Size(S)
500
Imprint Code
NATCO 30
SCH
Rx
Rating
AB
Description

Capsule with dark blue body and pink cap, printed NATCO on cap and 30 on body with white ink

Product Type :
Pharmaceuticals
Alternative :
Keppra
NDC
51991-0651-16
Strength
100mg/mL
Size(S)
16oz
Case Pack Units
12
SCH
Rx
Rating
AA
Description

clear, colorless to light yellow, grape-flavored liquid

Product Type :
Medical Foods
Alternative :
Deplin 15
NDC
51991-0809-90
Strength
15mg
Size(S)
90
Imprint Code
LMF 15
Description

Orange oval-coated caplet, imprinted “LMF” on one side and 15 on the other side.

 

 

Product Type :
Medical Foods
Alternative :
Deplin Capsules
NDC
51991-0908-90
Strength
7.5mg
Size(S)
90
Imprint Code
B / 908
Description

Orange Cap/Opaque White body, Imprinted B in white ink on the cap and 908 in orange ink on the body.

 

 

NDC
51991-0909-90
Strength
15mg
Size(S)
90
Imprint Code
15 / AG
Description

Opaque White Caps/Opaque White body, Imprinted 15 in red ink on the cap and AG in red ink on the body.

 

 

 

Product Type :
Medical Foods
Alternative :
Deplin
NDC
51991-0808-33
Strength
7.5mg
Size(S)
30
NDC
51991-0808-90
Strength
7.5mg
Size(S)
90
Imprint Code
LMF 7.5
Description

Round light-blue tablet, imprinted with “LMF” on one side and “7.5” on the other side. 

 

 

Product Type :
Medical Foods
Alternative :
Cerefolin NAC
NDC
51991-0911-90
Size(S)
90
Imprint Code
LMF 6RF
Description

Oval coated beige colored caplets, Debossed with LMF on one side and 6RF on the other side.

Covered by one or more of the following United States patents or patent applications:

 

7,709,460

 

Product Type :
Pharmaceuticals
Alternative :
Glucophage
NDC
51991-0805-05
Strength
500mg
Size(S)
500
NDC
51991-0805-10
Strength
500mg
Size(S)
1000
Imprint Code
101
SCH
Rx
Rating
AB
Description

white to off-white, oval, biconvex, film coated tablets with “ ” debossed on one side and “101” debossed on the opposite side.

NDC
51991-0806-01
Strength
850mg
Size(S)
100
NDC
51991-0806-05
Strength
850mg
Size(S)
500
Imprint Code
102
SCH
Rx
Rating
AB
Description

white to off-white, oval, biconvex, film coated tablets with “?” debossed on one side and “102” debossed on the opposite side

NDC
51991-0807-05
Strength
1000mg
Size(S)
500
NDC
51991-0807-10
Strength
1000mg
Size(S)
1000
Imprint Code
? 103
SCH
Rx
Rating
AB
Description

white to off-white, oval, biconvex, film coated tablets with ?103” debossed on one side and a bisect line on both sides

Product Type :
Pharmaceuticals
Alternative :
Methylin
NDC
51991-0611-50
Strength
5mg/5mL
Size(S)
500ml
Case Pack Units
6
SCH
CII
Rating
AA
Description

Colorless, grape-flavored liquid

NDC
51991-0612-50
Strength
10mg/5mL
Size(S)
500ml
Case Pack Units
6
SCH
CII
Rating
AA
Description

clear colorless to pale yellow, grape-scented liquid.

Product Type :
Pharmaceuticals
Alternative :
Avelox
NDC
51991-0943-33
Strength
400 mg
Size(S)
30
Case Pack Units
24
Imprint Code
400
SCH
Rx
Rating
AB
Description

Pale Red, Capsule-shaped, Film-coated Tablet. Imprinted with 400 on one side

Product Type :
Pharmaceuticals
Alternative :
Viramune
NDC
51991-0331-06
Strength
200mg
Size(S)
60
SCH
Rx
Rating
AB
Description

White or off white oval, biconvex tablet, embossed "H9050" on one side, single bisect on opposite side

Product Type :
Pharmaceuticals
Alternative :
Prilosec
NDC
51991-0643-10
Strength
20mg
Size(S)
1000
Case Pack Units
12
Imprint Code
OM 20
SCH
Rx
Rating
AB
Description

Opaque White, Hard Gelatin Capsules, Coded in Black Ink OM on the cap and 10 on the body

NDC
51991-0644-05
Strength
40mg
Size(S)
500
Case Pack Units
12
Imprint Code
OM 40
SCH
Rx
Rating
AB
Description

Opaque White, Hard Gelatin Capsules, Coded in Black Ink OM on the cap and 40 on the body

Product Type :
Pharmaceuticals
Alternative :
Trileptal®
NDC
51991-0292-01
Strength
150mg
Size(S)
100
Case Pack Units
12
NDC
51991-0292-05
Strength
150mg
Size(S)
500
Case Pack Units
12
Imprint Code
B 292
SCH
Rx
Rating
AB
Description

Beige, film-coated, modified oval tablet scored on both sides, debossed "B2" on one side "92" on other

NDC
51991-0293-01
Strength
300mg
Size(S)
100
Case Pack Units
12
NDC
51991-0293-05
Strength
300mg
Size(S)
500
Case Pack Units
12
Imprint Code
B293
SCH
Rx
Rating
AB
Description

Beige, film-coated, modified oval tablet scored on both sides, debossed "B293" on one side

NDC
51991-0294-01
Strength
600mg
Size(S)
100
Case Pack Units
12
NDC
51991-0294-05
Strength
600mg
Size(S)
500
Case Pack Units
12
Imprint Code
B294
SCH
Rx
Rating
AB
Description

Beige, film-coated, modified oval tablet scored on both sides, debossed "B294" on one side

Product Type :
Non-Prescription
Alternative :
Miralax OTC
NDC
51991-0961-58
Strength
3350NF
Size(S)
238gm
Case Pack Units
12
SCH
OTC
Rating
A
Description

Non-Prescription, White Powder for reconstitution, supplied with measured dosing cup marked to contain 17 grams of powder when filled to the indicated line.

NDC
51991-0962-57
Strength
3350NF
Size(S)
510gm
Case Pack Units
12
SCH
OTC
Rating
A
Description

Non-Prescription, White Powder for reconstitution, supplied with measured dosing cup marked to contain 17 grams of powder when filled to the indicated line.

Product Type :
Pharmaceuticals
Alternative :
Miralax - Prescription
NDC
51991-0457-58
Strength
3350 NF
Size(S)
255gm
NDC
51991-0457-57
Strength
3350 NF
Size(S)
527gm
SCH
Rx
Rating
AA
Description

Prescription - White Powder for reconstitution, supplied with measured dosing cup marked to contain 17 grams of powder when filled to the indicated line.

11/2/2018 - This product is no longer available as a prescription. 

Product Type :
Pharmaceuticals
Alternative :
Exelon
NDC
51991-0897-30
Strength
4.6mg/24 hrs
Size(S)
30
Case Pack Units
24
SCH
Rx
Rating
AB
Description

Each patch of 5cm² contains 9mg rivastimine base with in vivo release rate of 4.6mg/24hours.

Individually Sealed Pouches containing 1 patch in each

NDC
51991-0898-30
Strength
9.5mg/24 hrs
Size(S)
30
Case Pack Units
24
SCH
Rx
Rating
AB
Description

Each patch of 10cm² contains 18mg rivastimine base with in vivo release rate of 9.5mg/24hours.

Individually Sealed Pouches containing 1 patch in each

NDC
51991-0899-30
Strength
13.3mg/24 hrs
Size(S)
30
Case Pack Units
24
SCH
Rx
Rating
AB
Description

Each patch of 5cm² contains 27mg rivastimine base with in vivo release rate of 13.3mg/24hours.

Individually Sealed Pouches containing 1 patch in each

Product Type :
Pharmaceuticals
Alternative :
Maxalt MLT
NDC
51991-0362-78
Strength
5mg
Size(S)
18
Case Pack Units
12
Imprint Code
5
SCH
Rx
Rating
AB
Description

White to Off-white, round, uncoated tablets, debossed "5" on one side and plain on the other side

NDC
51991-0363-78
Strength
10mg
Size(S)
18
Case Pack Units
12
Imprint Code
10
SCH
Rx
Rating
AB
Description

White to Off-white, round, uncoated tablets, debossed "10" on one side and plain on the other side

Product Type :
Pharmaceuticals
Alternative :
Maxalt
NDC
51991-0354-78
Strength
5mg
Size(S)
18
Case Pack Units
12
Imprint Code
NAT 123
SCH
Rx
Rating
AB
Description

Light pink to pink-colored, capsule-shaped, biconvex, uncoated tablet with “NAT” on one side and “123” on the other side

NDC
51991-0355-78
Strength
10mg
Size(S)
18
Case Pack Units
12
Imprint Code
NAT 121
SCH
Rx
Rating
AB
Description

Light pink to pink-colored, capsule-shaped, biconvex, uncoated tablet with “NAT” on one side and “121” on the other side

Product Type :
Pharmaceuticals
Alternative :
Quelicin
NDC
51991-0964-25
Strength
200mg/10mL
Size(S)
bx/25
Case Pack Units
16
SCH
Rx
Rating
AP
Description

WARNING:  Paralyzing Agent 

Breckenridge is committed to improving each patient’s quality of life and does not approve of the sale of its products for use in capital punishment. As such, Breckenridge is limiting the distribution of its succinylcholine chloride product to wholesalers and distributors who agree not to resell these products for use by correctional institutions.

 

Clear, colorless solution.  Store in refrigerator.

Product Type :
Pharmaceuticals
Alternative :
Lamisil
NDC
51991-0526-33
Strength
250mg
Size(S)
30
Case Pack Units
72
NDC
51991-0526-01
Strength
250mg
Size(S)
100
Case Pack Units
72
Imprint Code
B 526
SCH
Rx
Rating
AB
Description

White, oblong, unscored tablet debossed "B" and "526" on one side

Product Type :
Pharmaceuticals
Alternative :
Surmontil
NDC
51991-0944-01
Strength
25mg
Size(S)
100
Case Pack Units
6
Imprint Code
TR25
SCH
Rx
Rating
AB
Description

#3 Capsules with Yellow Opaque body and Blue Opaque cap, Imprinted with TR25 in black ink on the cap.

NDC
51991-0945-01
Strength
50mg
Size(S)
100
Case Pack Units
6
Imprint Code
TR50
SCH
Rx
Rating
AB
Description

#2 Capsules with Orange Opaque body and Blue Opaque cap, Imprinted with TR50 in black ink on the cap.

NDC
51991-0946-01
Strength
100mg
Size(S)
100
Case Pack Units
6
Imprint Code
TR100
SCH
Rx
Rating
AB
Description

#0 Capsules with White Opaque body and Light Blue Opaque cap, Imprinted with TR100 in black ink on the cap.