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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-688
Application NumberANDA210955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-687
Application NumberANDA210955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-686
Application NumberANDA210955
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
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