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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
Effective Date
May 19, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Bisoprolol(2.5 mg in 1 1)
Hydrochlorothiazide(6.25 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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
50090-6478
Application Number
NDA020186
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
October 5, 2022
Code: UR59KN573LClass: ACTIBQuantity: 2.5 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1
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