Zolpidem (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Zolpidem Tartrate Tablets
5 mg/100 Tablets
NDC 0143-9962-01

Zolpidem Tartrate Tablets
5 mg/100 Tablets
(click image for full-size original)

Zolpidem Tartrate Tablets
10 mg/100 Tablets
NDC 0143-9963-01

Zolpidem Tartrate Tablets
10 mg/100Tablets
(click image for full-size original)
ZOLPIDEM
zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9962
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSES
Product Characteristics
Color RED (RED) Score no score
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code W62
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9962-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0143-9962-05 500 TABLET (500 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078129 04/30/2008
ZOLPIDEM
zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9963
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
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code W63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9963-01 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0143-9963-05 500 TABLET (500 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078129 04/30/2008
Labeler — West-ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
Hikma Pharmaceutical 534661645 MANUFACTURE

Revised: 03/2011 West-ward Pharmaceutical Corp

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