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FDA Approval

triamterene and hydrochlorothiazide

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

FDA Approval Summary

Company
Effective Date
October 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Triamterene(75 mg in 1 1)
Hydrochlorothiazide(50 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.

triamterene and hydrochlorothiazide

Product Details

NDC Product Code
50090-6736
Application Number
ANDA208360
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 26, 2023
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: WS821Z52LQClass: ACTIBQuantity: 75 mg in 1 1
Code: 0J48LPH2THClass: ACTIBQuantity: 50 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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