Bisoprolol Fumarate

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Aurobindo Pharma Limited

DUNS Number

650082092

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Aurobindo Pharma Limited

Labeler

NorthStar Rx LLC

Registrant

Aurobindo Pharma Limited

DUNS Number

918917642

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

16714-530

Application Number

ANDA077910

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 13, 2022

Ingredients

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT