Hydrochlorothiazide

Product NDC: 82804-973
11-digit product format: 828040973
Labeler code: 82804
Product ID: 82804-973_4c1a2fb9-133d-4bd5-a336-e47d54f22c97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA087068
Marketing category: ANDA
Marketing start: 2020-09-25
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

Additional Listing Data

Ingredient	Strength
HYDROCHLOROTHIAZIDE	50 mg/1

Field	Values
Unii	0J48LPH2TH
Rxcui	197770, 310798

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
82804-973-00	82804097300	100 TABLET in 1 BOTTLE (82804-973-00)	100 tablet	2025-02-13	No	No	Historical
82804-973-11	82804097311	1000 TABLET in 1 BOTTLE (82804-973-11)	1000 tablet	2025-02-13	No	No	Historical
82804-973-30	82804097330	30 TABLET in 1 BOTTLE (82804-973-30)	30 tablet	2025-02-13	No	No	Historical
82804-973-55	82804097355	500 TABLET in 1 BOTTLE (82804-973-55)	500 tablet	2025-02-13	No	No	Historical
82804-973-60	82804097360	60 TABLET in 1 BOTTLE (82804-973-60)	60 tablet	2025-02-13	No	No	Historical
82804-973-72	82804097372	120 TABLET in 1 BOTTLE (82804-973-72)	120 tablet	2025-02-13	No	No	Historical
82804-973-90	82804097390	90 TABLET in 1 BOTTLE (82804-973-90)	90 tablet	2025-02-13	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS, USP Rx Only	Proficient Rx LP	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	1