Alprazolam (Page 8 of 8)

HOW SUPPLIED

Alprazolam tablets, USP for oral administration are available as:

0.5 mg: Oval, peach tablets debossed GG 257 on one side and scored on the reverse side and supplied as:

NDC 66267-760-03 bottles of 3

NDC 66267-760-06 bottles of 6

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

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.

09-2011M

7383

Sandoz Inc.

Princeton, NJ 08540

0.5 mg Label

pdp
(click image for full-size original)

ALPRAZOLAM
alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66267-760(NDC:0781-1077)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DOCUSATE SODIUM
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM BENZOATE
STARCH, CORN
Product Characteristics
Color orange (PEACH) Score 2 pieces
Shape OVAL (OVAL) Size 9mm
Flavor Imprint Code GG257
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66267-760-03 3 TABLET in 1 BOTTLE None
2 NDC:66267-760-06 6 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074112 12/29/1995
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (66267-760)

Revised: 01/2021 NuCare Pharmaceuticals, Inc.

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