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 for Oral Use Initial U.S. Approval: 1992
Approved
Approval ID
a0c8c0ac-863c-4385-94d2-f6691bee66d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 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 Code21695-950
Application NumberANDA076862
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol Succinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2010
FDA Product Classification
INGREDIENTS (14)
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 50 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT