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Metoclopramide

METOCLOPRAMIDE TABLETS, USP

Approved
Approval ID

f32d6e27-5b7b-4b17-af2e-0250447ee560

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2010

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

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 Code21695-485
Application NumberANDA072750
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: W1792A2RVD
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

Metoclopramide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-346
Application NumberANDA071250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoclopramide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2009
FDA Product Classification

INGREDIENTS (6)

METOCLOPRAMIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: W1792A2RVD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Metoclopramide - FDA Drug Approval Details