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

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.