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METOPROLOL TARTRATE

Metoprolol Tartrate Tablets USPRevised: December 2008Rx only174366

Approved
Approval ID

0d739f0c-a206-4d70-9f63-af1c87005d83

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 26, 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.

METOPROLOL TARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-317
Application NumberANDA074217
Product Classification
M
Marketing Category
C73584
G
Generic Name
METOPROLOL TARTRATE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2010
FDA Product Classification

INGREDIENTS (13)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METOPROLOL TARTRATEActive
Quantity: 50 mg in 1 1
Code: W5S57Y3A5L
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT

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METOPROLOL TARTRATE - FDA Drug Approval Details