MedPath
FDA Approval

Meperidine Hydrochloride

January 24, 2024

HUMAN PRESCRIPTION DRUG LABEL

Meperidine(50 mg in 5 mL)

Manufacturing Establishments (1)

West-Ward Columbus Inc.

Hikma Pharmaceuticals USA Inc.

058839929

Products (4)

Meperidine Hydrochloride

0054-3545

ANDA088744

ANDA (C73584)

ORAL

April 18, 2020

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 5 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MALTOLInactive
Code: 3A9RD92BS4Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Meperidine Hydrochloride

0054-4595

ANDA040110

ANDA (C73584)

ORAL

April 18, 2020

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT

Meperidine Hydrochloride

0054-4596

ANDA040110

ANDA (C73584)

ORAL

April 18, 2020

Code: N8E7F7Q170Class: ACTIBQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT

Meperidine Hydrochloride

0054-8595

ANDA040110

ANDA (C73584)

ORAL

April 18, 2020

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
© Copyright 2025. All Rights Reserved by MedPath