MedPath
FDA Approval

DEMEROL

December 28, 2011

Human prescription drug label

Meperidine(100 mg in 1 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (5)

DEMEROL

54868-3610

NDA021171

NDA (C73594)

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

December 28, 2011

Code: N8E7F7Q170Class: ACTIBQuantity: 100 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
METACRESOLInactive
Code: GGO4Y809LOClass: IACT

DEMEROL

54868-5808

NDA021171

NDA (C73594)

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

December 28, 2011

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

DEMEROL

54868-0616

NDA021171

NDA (C73594)

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

December 28, 2011

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
METACRESOLInactive
Code: GGO4Y809LOClass: IACT

DEMEROL

54868-4751

NDA021171

NDA (C73594)

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

December 28, 2011

Code: N8E7F7Q170Class: ACTIBQuantity: 100 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

DEMEROL

54868-3230

NDA021171

NDA (C73594)

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

December 28, 2011

Code: N8E7F7Q170Class: ACTIBQuantity: 50 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

meperidine hydrochloride injection, USP

CII

Rx only


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