Ambien CR
These highlights do not include all the information needed to use Ambien CR safely and effectively. See full prescribing information for Ambien CR. Ambien CR (zolpidem tartrate extended-release) tablets - CIVInitial U.S. Approval: 1992
Approved
Approval ID
968b5154-3c38-4f20-bbeb-495bcb91cc2b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zolpidem tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-213
Application NumberNDA021774
Product Classification
M
Marketing Category
C73594
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2009
FDA Product Classification
INGREDIENTS (11)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
zolpidem tartrateActive
Quantity: 12.5 mg in 1 1
Code: WY6W63843K
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
potassium bitartrateInactive
Code: NPT6P8P3UU
Classification: IACT
zolpidem tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-319
Application NumberNDA021774
Product Classification
M
Marketing Category
C73594
G
Generic Name
zolpidem tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2009
FDA Product Classification
INGREDIENTS (10)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
zolpidem tartrateActive
Quantity: 6.25 mg in 1 1
Code: WY6W63843K
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
potassium bitartrateInactive
Code: NPT6P8P3UU
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT