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 useInitial U.S. Approval: 1979
Approved
Approval ID
797aad80-0597-42f8-99d5-39de180c3b5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-295
Application NumberNDA017854
Product Classification
M
Marketing Category
C73605
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Metoclopramide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-296
Application NumberNDA017854
Product Classification
M
Marketing Category
C73605
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (5)
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT