DEMEROL
Demerol
Approved
Approval ID
53ddfe26-5a7e-4f39-8904-829a03538f63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MEPERIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3610
Application NumberNDA021171
Product Classification
M
Marketing Category
C73594
G
Generic Name
MEPERIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (4)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: N8E7F7Q170
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
MEPERIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5808
Application NumberNDA021171
Product Classification
M
Marketing Category
C73594
G
Generic Name
MEPERIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (3)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: N8E7F7Q170
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MEPERIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0616
Application NumberNDA021171
Product Classification
M
Marketing Category
C73594
G
Generic Name
MEPERIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (4)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: N8E7F7Q170
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
MEPERIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4751
Application NumberNDA021171
Product Classification
M
Marketing Category
C73594
G
Generic Name
MEPERIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (3)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: N8E7F7Q170
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MEPERIDINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3230
Application NumberNDA021171
Product Classification
M
Marketing Category
C73594
G
Generic Name
MEPERIDINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (3)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: N8E7F7Q170
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 2/6/2007
meperidine hydrochloride injection, USP
CII
Rx only