Reglan
These highlights do not include all the information needed to use REGLAN TABLETS safely and effectively. See full prescribing information for REGLAN TABLETS. REGLAN (metoclopramide) tablets, for oral useInitial U.S. Approval: 1979
Approved
Approval ID
de55c133-eb08-4a35-91a2-5dc093027397
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2020
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 Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-165
Application NumberNDA017854
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoclopramide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
Metoclopramide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-166
Application NumberNDA017854
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metoclopramide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT