Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisoprolol Fumarate
Product Details
NDC Product Code
29300-127Application Number
ANDA078635Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 28, 2022BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Bisoprolol Fumarate
Product Details
NDC Product Code
29300-126Application Number
ANDA078635Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 28, 2022BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
SPL UNCLASSIFIED SECTION
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind. Estate, Pilerne, Bardez,
Goa 403 511, India.
Manufactured for:
East Brunswick, NJ 08816.
04-R-05/2019
13011574