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Metoclopramide

METOCLOPRAMIDE TABLETS, USP

Approved
Approval ID

80fb18a3-824a-4360-947e-63f0a167245b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Metoclopramide

PRODUCT DETAILS

NDC Product Code53808-0722
Application NumberANDA071250
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 7, 2010
Generic NameMetoclopramide

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

Metoclopramide

PRODUCT DETAILS

NDC Product Code53808-0723
Application NumberANDA072750
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 7, 2010
Generic NameMetoclopramide

INGREDIENTS (8)

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