Alprazolam (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

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ALPRAZOLAM alprazolam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-993(NDC:51991-705)
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
Product Characteristics
Color orange (light orange to orange) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code B705
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-993-30 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
Labeler — medsource pharmaceuticals (833685915)
Registrant — Centaur Pharmaceuticals Private Limited (918629361)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-993)

Revised: 12/2019 medsource pharmaceuticals

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