Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Glenmark Pharmaceuticals Limited
GLENMARK PHARMACEUTICALS INC., USA
862603186
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisoprolol Fumarate and Hydrochlorothiazide
Product Details
NDC Product Code
68462-878Application Number
ANDA215995Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2024HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1
BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 2.5 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Bisoprolol Fumarate and Hydrochlorothiazide
Product Details
NDC Product Code
68462-880Application Number
ANDA215995Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2024HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1
BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Bisoprolol Fumarate and Hydrochlorothiazide
Product Details
NDC Product Code
68462-879Application Number
ANDA215995Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2024BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 5 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT