Alprazolam (Page 8 of 8)

ALPRAZOLAM TABLET

Label Image
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ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-0341(NDC:51991-707)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (light blue to blue) Score 4 pieces
Shape RECTANGLE Size 15mm
Flavor Imprint Code B707
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-0341-2 20 TABLET in 1 BOTTLE None
2 NDC:53002-0341-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207507 07/09/2018 10/31/2025
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-0341), REPACK (53002-0341)

Revised: 08/2023 RPK Pharmaceuticals, Inc.

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