Nadolol
Nadolol Tablets, USP
Approved
Approval ID
a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-800
Application NumberANDA074501
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2009
FDA Product Classification
INGREDIENTS (9)
NADOLOLActive
Quantity: 80 mg in 1 1
Code: FEN504330V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nadolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-799
Application NumberANDA074501
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2009
FDA Product Classification
INGREDIENTS (9)
NADOLOLActive
Quantity: 40 mg in 1 1
Code: FEN504330V
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nadolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-802
Application NumberANDA074501
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2009
FDA Product Classification
INGREDIENTS (9)
NADOLOLActive
Quantity: 20 mg in 1 1
Code: FEN504330V
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT