MedPath

Nadolol

Rx Only

Approved
Approval ID

9cf4ca73-2d38-44c2-a522-d44d536b5e55

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 26, 2024

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Nadolol

PRODUCT DETAILS

NDC Product Code72162-2233
Application NumberANDA203455
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 17, 2018
Generic NameNadolol

INGREDIENTS (7)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NADOLOLActive
Quantity: 40 mg in 1 1
Code: FEN504330V
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Nadolol - FDA Drug Approval Details