Metoclopramide
These highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. Metoclopramide tablets, for oral use Initial U.S. Approval: 1979
Approved
Approval ID
b16ad17c-eeea-407e-91e4-36506e9aa698
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
ScieGen Pharmaceuticals, Inc.
DUNS: 079391286
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metoclopramide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-232
Application NumberANDA072215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (4)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
Metoclopramide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-233
Application NumberANDA072215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (4)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM