MedPath

Nadolol

Rx Only

Approved
Approval ID

2fc1f850-9653-4082-929a-926b644810e7

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72162-2234
Application NumberANDA203455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2018
FDA Product Classification

INGREDIENTS (7)

NADOLOLActive
Quantity: 20 mg in 1 1
Code: FEN504330V
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Nadolol - FDA Drug Approval Details