Prescription Drug Information: Zolpidem Tartrate (Page 6 of 6)

Zolpidem Tartrate

Label ImageLabel Image
ZOLPIDEM TARTRATE zolpidem tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3878(NDC:65862-160)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 9mm
Flavor Imprint Code E;79
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-3878-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-3878-0 10 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078413 05/04/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-3878), REPACK (50090-3878)

Revised: 08/2022 A-S Medication Solutions

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