Nadolol
Rx Only
Approved
Approval ID
16d317c0-829a-4233-b1aa-b96348c4ca25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2017
Manufacturers
FDA
InvaGen Pharmaceuticals Inc.
DUNS: 165104469
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 Code67787-348
Application NumberANDA203455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2017
FDA Product Classification
INGREDIENTS (7)
NADOLOLActive
Quantity: 40 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
Nadolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67787-347
Application NumberANDA203455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2017
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
NADOLOLActive
Quantity: 20 mg in 1 1
Code: FEN504330V
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Nadolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67787-349
Application NumberANDA203455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2017
FDA Product Classification
INGREDIENTS (7)
NADOLOLActive
Quantity: 80 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
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT