MedPath

Metoprolol succinate

Approved
Approval ID

ad097646-cc77-8d67-5974-cc00060409f2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 20, 2023

Manufacturers
FDA

Northstar Rx LLC

DUNS: 830546433

Products 2

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 Code72603-142
Application NumberANDA090617
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2023
FDA Product Classification

INGREDIENTS (14)

Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 25 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR

Metoprolol succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72603-143
Application NumberANDA090617
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metoprolol succinate
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2023
FDA Product Classification

INGREDIENTS (14)

ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
METOPROLOL SUCCINATEActive
Quantity: 50 mg in 1 1
Code: TH25PD4CCB
Classification: ACTIR
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT

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