Hydrochlorothiazide

Product NDC: 72789-303
11-digit product format: 727890303
Labeler code: 72789
Product ID: 72789-303_3cf6edf5-e1bb-570f-e063-6294a90af580
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040907
Marketing category: ANDA
Marketing start: 2008-08-15
Substance: HYDROCHLOROTHIAZIDE
Active strength: 50 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72789-303_3cf6edf5-e1bb-570f-e063-6294a90af580
SPL ID: 3cf6edf5-e1bb-570f-e063-6294a90af580
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Hydrochlorothiazide
Generic name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Marketing start: 2008-08-15
Marketing category: ANDA
Application number: ANDA040907
Pharmacologic classes: Increased Diuresis [PE]; Thiazide Diuretic [EPC]; Thiazides [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
HYDROCHLOROTHIAZIDE	50 mg/1

Package NDC	Description	Marketing start	Sample
72789-303-01	100 TABLET in 1 BOTTLE, PLASTIC (72789-303-01)	2022-03-02	No

UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-303-01	72789030301	100 TABLET in 1 BOTTLE, PLASTIC (72789-303-01)	100 tablet	2022-03-02	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Hydrochlorothiazide Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	15