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
447dbb34-7903-4e6a-be31-48a0b0e0d2f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2021
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metoclopramide
PRODUCT DETAILS
NDC Product Code51079-886
Application NumberANDA072801
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2021
Generic NameMetoclopramide
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Metoclopramide
PRODUCT DETAILS
NDC Product Code51079-888
Application NumberANDA070184
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2021
Generic NameMetoclopramide
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
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