Demerol
These highlights do not include all the information needed to use DEMEROL TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942
Approved
Approval ID
5cb2674c-a70d-4022-9188-3f711cccff5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2023
Manufacturers
FDA
Validus Pharmaceuticals LLC
DUNS: 801194619
Products 2
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 Code30698-335
Application NumberNDA005010
Product Classification
M
Marketing Category
C73594
G
Generic Name
Meperidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (6)
MEPERIDINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: N8E7F7Q170
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Meperidine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-337
Application NumberNDA005010
Product Classification
M
Marketing Category
C73594
G
Generic Name
Meperidine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (6)
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MEPERIDINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: N8E7F7Q170
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT