MedPath
FDA Approval

Zolpidem

December 6, 2023

HUMAN PRESCRIPTION DRUG LABEL

Zolpidem(10 mg in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products (1)

Zolpidem

68071-3455

ANDA077214

ANDA (C73584)

ORAL

December 6, 2023

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ZolpidemActive
Code: WY6W63843KClass: ACTIBQuantity: 10 mg in 1 1
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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