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Metoprolol Succinate

These highlights do not include all the information needed to use metoprolol succinate extended-release tablets USP safely and effectively. See full prescribing information for metoprolol succinate extended release tablets USP. Metoprolol succinate extended-release tablets USP Initial U.S. Approval: 1992

Approved
Approval ID

7e87a7ee-b16e-464a-a77c-0f7a40e04cf7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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

Metoprolol Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-972
Application NumberANDA077298
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2011
FDA Product Classification

INGREDIENTS (14)

METOPROLOL SUCCINATEActive
Quantity: 100 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

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Metoprolol Succinate - FDA Drug Approval Details