Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alkem Laboratories Limited
Ascend Laboratories, LLC
915628612
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nebivolol
Product Details
NDC Product Code
67877-390Application Number
ANDA203828Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 13, 2023HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 20 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Nebivolol
Product Details
NDC Product Code
67877-391Application Number
ANDA203828Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 13, 2023NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 10 mg in 1 1
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Nebivolol
Product Details
NDC Product Code
67877-392Application Number
ANDA203828Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 13, 2023NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Nebivolol
Product Details
NDC Product Code
67877-393Application Number
ANDA203828Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 13, 2023NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 2.5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT