REGLAN
reglan tablets (metoclopramide tablets, USP)
Approved
Approval ID
55f1ee88-a455-44ba-b51a-2fcefe8eda65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
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 Code16590-906
Application NumberNDA017854
Product Classification
M
Marketing Category
C73594
G
Generic Name
METOCLOPRAMIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2010
FDA Product Classification
INGREDIENTS (5)
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT