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Metoclopramide

Metoclopramide Oral Solution USP 5 mg/5 mL Rx Only

Approved
Approval ID

14114420-fee0-4850-b99e-cdb5f421cd33

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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 Code63629-2144
Application NumberANDA071402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2015
FDA Product Classification

INGREDIENTS (9)

METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: W1792A2RVD
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

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Metoclopramide - FDA Drug Approval Details