Hydrochlorothiazide

Product NDC: 63187-074
Requested package NDC: 63187-074-30
11-digit product format: 631870074
Labeler code: 63187
Product ID: 63187-074_2d8c4763-f719-46ce-8fb8-04e82fbacf05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA040807
Marketing category: ANDA
Marketing start: 2010-08-20
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-074	63187-074-30	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-074	63187-074-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-074	63187-074-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040807-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	2007-07-20
A040807-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	2007-07-20
A040807-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	2007-07-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040807-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040807-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040807-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040807-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040807-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040807-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040807-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040807-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040807-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040807-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040807-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040807-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040807-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040807-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040807-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040807-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040807-001	AB	1	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-074	HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	4	Legacy NDC	20191121_7288899f-f4a8-454d-b407-23494cc9118f.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-074-30	63187007430	30 TABLET in 1 BOTTLE (63187-074-30)	30 tablet	2018-11-01	0000-00-00	No	No	Current