Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Impax Laboratories, Inc
Impax Generics
790947167
Packaging Coordinators, LLC
Impax Generics
078525133
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nadolol and Bendroflumethiazide
Product Details
NDC Product Code
0115-5311Application Number
ANDA077833Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 15, 2016BendroflumethiazideActive
Code: 5Q52X6ICJIClass: ACTIBQuantity: 5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
NadololActive
Code: FEN504330VClass: ACTIBQuantity: 40 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Nadolol and Bendroflumethiazide
Product Details
NDC Product Code
0115-5322Application Number
ANDA077833Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 15, 2016BendroflumethiazideActive
Code: 5Q52X6ICJIClass: ACTIBQuantity: 5 mg in 1 1
NadololActive
Code: FEN504330VClass: ACTIBQuantity: 80 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT