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
998f1782-bbfa-469b-9fe1-c612e8588f70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-631
Application NumberANDA070184
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Metoclopramide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-620
Application NumberANDA072801
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM