Alprazolam (Page 7 of 7)

ANIMAL STUDIES

When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

Manufactured for:

DAVA Pharmaceuticals, Inc.

Fort Lee, NJ 07024, USA

By:

ULTRAtab Laboratories, Inc.

Highland, NY 12528, USA

Rev. 09/10

DESCRIPTION

Alprazolam Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-1] [1,4] benzodiazepine.

The structural formula is represented to the right:

Structure

Alprazolam is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.

Each ALPRAZOLAM Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.

Inactive ingredients: crospovidone, docusate sodium, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium benzoate and starch 1500. In addition, the 0.5 mg tablet contains D&C Yellow No. 10 and the 1 mg and 2 mg tablet contains Green Lake Blend.

Principal Display Panel

Alprazolam Tablets, USP 0.25mg CIV

30 Tablets

NDC 10544-118-30

0.25mg 30ct
(click image for full-size original)
ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-118(NDC:67253-900)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM .25 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
DOCUSATE SODIUM
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BENZOATE
STARCH, CORN
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S900
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-118-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074174 05/22/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-118)

Revised: 10/2015 Blenheim Pharmacal, Inc.

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