NDC Code(s) : 13668-007-15, 13668-007-01, 13668-007-90, 13668-007-10, 13668-007-30, 13668-007-05, 13668-008-90, 13668-008-05, 13668-008-01, 13668-008-10, 13668-008-30, 13668-008-15
Packager : Torrent Pharmaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZOLPIDEM TARTRATEzolpidem tartrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-007
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color red (Red) Score no score
Shape CAPSULE (Capsule) Size 10 mm
Flavor Imprint Code 5MG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-007-151500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:13668-007-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:13668-007-9090 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
4NDC:13668-007-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:13668-007-3030 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
6NDC:13668-007-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
ZOLPIDEM TARTRATEzolpidem tartrate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-008
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE(UNII: WY6W63843K)
(ZOLPIDEM - UNII:7K383OQI23) 		ZOLPIDEM TARTRATE10 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow (peach-yellow) Score no score
Shape CAPSULE (Capsule) Size 10 mm
Flavor Imprint Code 10MG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-008-9090 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:13668-008-05500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:13668-008-01100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
4NDC:13668-008-101000 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:13668-008-3030 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
6NDC:13668-008-151500 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007

LABELER - Torrent Pharmaceuticals Limited(916488547)

REGISTRANT - Torrent Pharma, Inc.(790033935)

Establishment
Name Address ID/FEI Business Operations
Torrent Pharmaceuticals Limited 864147745 analysis(13668-007, 13668-008), pack(13668-007, 13668-008), manufacture(13668-007, 13668-008), api manufacture(13668-007, 13668-008)

Establishment
Name Address ID/FEI Business Operations
Torrent Pharmaceuticals Limited 916488547 manufacture(13668-007, 13668-008), analysis(13668-007, 13668-008), pack(13668-007, 13668-008), api manufacture(13668-007, 13668-008)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 5 mg: (Indrad site)

Label

PRINCIPAL DISPLAY PANEL – 10 mg: (Indrad site)

Label

PRINCIPAL DISPLAY PANEL – 5 mg: (Bharuch site)

Label

PRINCIPAL DISPLAY PANEL – 10 mg: (Bharuch site)

Label