Nadolol
Nadolol Tablets
Approved
Approval ID
3332d348-4ef9-47bb-8354-3101244b299b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nadolol
PRODUCT DETAILS
NDC Product Code10135-688
Application NumberANDA210955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 4, 2023
Generic NameNadolol
INGREDIENTS (10)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
NADOLOLActive
Quantity: 80 mg in 1 1
Code: FEN504330V
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Nadolol
PRODUCT DETAILS
NDC Product Code10135-687
Application NumberANDA210955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 4, 2023
Generic NameNadolol
INGREDIENTS (10)
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
NADOLOLActive
Quantity: 40 mg in 1 1
Code: FEN504330V
Classification: ACTIB
Nadolol
PRODUCT DETAILS
NDC Product Code10135-686
Application NumberANDA210955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 4, 2023
Generic NameNadolol
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
NADOLOLActive
Quantity: 20 mg in 1 1
Code: FEN504330V
Classification: ACTIB