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HYDROCHLOROTHIAZIDE

ANDA

HYDROCHLOROTHIAZIDE | A040412 | PRINSTON PHARMACEUTICAL INC

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 5 NDCs

Highest NADAC/Unit

$0.0312

per ea

Lowest NADAC/Unit

$0.0114

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
43547039810HYDROCHLOROTHIAZIDE 50 MG TAB	$0.0312	EA	Generic	—	2026-10-21
43547039811HYDROCHLOROTHIAZIDE 50 MG TAB	$0.0312	EA	Generic	—	2026-10-21
43547039710HYDROCHLOROTHIAZIDE 25 MG TAB	$0.0114	EA	Generic	—	2026-10-21
43547039711HYDROCHLOROTHIAZIDE 25 MG TAB	$0.0114	EA	Generic	—	2026-10-21
60687059301HYDROCHLOROTHIAZIDE 25 MG TAB	$0.0114	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$2.06

Highest Price

$20.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43547-0397-10HYDROCHLOROTHIAZIDE 25MG TAB	$2.06	FSS	AvKare, LLC	06/14/2028
43547-0397-11HYDROCHLOROTHIAZIDE 25MG TAB	$18.89	FSS	AvKare, LLC	06/14/2028
43547-0398-10HYDROCHLOROTHIAZIDE 50MG TAB	$3.26	FSS	AvKare, LLC	06/14/2028
43547-0398-11HYDROCHLOROTHIAZIDE 50MG TAB	$20.95	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain18 active DMFs10 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLHYDROCHLOROTHIAZIDE

DMF 8811965

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 21151973

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 40281980

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 162782002

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 167072003

CHANGZHOU PHARMACEUTICAL FACTORYHYDROCHLOROTHIAZIDE

DMF 167502003

ZAKLADY FARMACEUTYCZNE POLPHARMA SAHYDROCHLOROTHIAZIDE

DMF 175992004

APITORIA PHARMA PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 177282004

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP, PROCESS II

DMF 185632005

VALENS MOLECULES PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 197212006

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP - PROCESS #2

DMF 205342007

CTX LIFE SCIENCES PVT LTDHYDROCHLOROTHIAZIDE USP

DMF 210392007

ZYDUS LIFESCIENCES LTDHYDROCHLOROTHIAZIDE USP

DMF 220272008

ALEMBIC PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 222532008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDHYDROCHLOROTHIAZIDE USP

DMF 225412008

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)HYDROCHLOROTHIAZIDE USP

DMF 258492012

MACLEODS PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 339232019

LAURUS LABS LTDHYDROCHLOROTHIAZIDE USP

DMF 418892025

MICRO CHEMS LTDInactiveHYDROCHLOROTHIAZIDE USP

DMF 10591967

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveHYDROCHLOROTHIAZIDE IN PHIL PA

DMF 44361982

LABORATORIOS JULIAN DE MEXICO SAInactiveHYDROCHLOROTHIAZIDE

DMF 44881982

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 45081982

CHANGZHOU PHARMACEUTICAL FACTORYInactiveHYDROCHLOROTHIAZIDE

DMF 49241983

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 51251983

SMITHKLINE AND BECKMAN INCInactiveHYDROCHLOROTHIAZIDE

DMF 56141984

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 60551985

UNICHEM LABORATORIES LTDInactiveHYDROCHLOROTHIAZIDE B.P.

DMF 62371985

SUZHOU LIXIN PHARMACEUTICAL CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 211812007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 29, 2002

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 29, 2002