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FDA Approval

bisoprolol fumarate and hydrochlorothiazide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Unichem Pharmaceuticals (USA), Inc.

DUNS: 181620514

Effective Date

January 10, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrochlorothiazide(6.25 mg in 1 1)

Bisoprolol(2.5 mg in 1 1)

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

29300-187

Application Number

ANDA079106

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 2.5 mg in 1 1

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

bisoprolol fumarate and hydrochlorothiazide

Product Details

NDC Product Code

29300-188

Application Number

ANDA079106

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 5 mg in 1 1

bisoprolol fumarate and hydrochlorothiazide

Product Details

NDC Product Code

29300-189

Application Number

ANDA079106

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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