Hydrochlorothiazide

Product NDC: 68071-3238
11-digit product format: 680713238
Labeler code: 68071
Product ID: 68071-3238_518be80a-9752-51b8-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA040907
Marketing category: ANDA
Marketing start: 2009-07-02
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-3238		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-3238	68071-3238-1	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3238-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3238-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3238-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3238-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3238-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3238-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3238-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3238-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3238-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A040907-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15
A040907-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15
A040907-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040907-001	AB
A040907-002	AB
A040907-003	AB

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 3 · 89 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
2026-08-18 06:07:40	2026-07	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040907-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040907-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040907-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040907-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040907-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040907-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040907-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040907-002	AB	1	`4b0b4de00fa7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3238-1	2025-01-30	C162847	48780-1	2cef2736-a580-d83d-e063-dadaa90ab31f	Hydrochlorothiazide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3238-1	Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3238	HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20230301_518be80a-9751-51b8-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unit Dose Solutions, Inc.	54f027ea-0a6e-7920-e063-6394a90ab6ae	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	8a1de4e2-3aca-a4d3-e053-2995a90a1a41	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	99f45e08-897d-44dd-b48d-aa6d78981f0c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	2fd8f595-7aec-4308-bb17-a6f2e7190044	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Coupler LLC	4ee35bcf-1eb0-1cca-e063-6294a90adeed	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	2ec371a5-18ba-4ce2-9725-7f99bb73454a	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	088cb67f-3eaa-4e78-9fbe-ad2d6b7c5707	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f1f99065-04d2-48ac-b25d-9595237c869c	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2f3b60a-bffe-2675-e053-2995a90ae96e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	9cd5d16e-3db7-4b25-847d-6de91543463b	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	67bedecc-f758-4bc6-82c5-7d428cbbbd9b	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d7d0867a-748e-4960-851f-ad764e07f774	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	73bc116a-2964-4acc-9ef0-0a3f66268913	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	33f3b980-b339-4dbf-99bd-05588c2a298c	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Redpharm drug	fa1c0b92-4360-bcfd-e053-6394a90a955a	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Direct_Rx	05156717-fe1b-22f1-e063-6394a90a3d10	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Lake Erie Medical DBA Quality Care Products LLC	9e6a0c83-1494-44ca-90e0-3f43fa8ec746	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	8bc8d5e2-a974-64ed-e053-2a95a90a8340	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	ff448eb4-b48f-46f5-ac30-f03aad08f9f5	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310798	hydroCHLOROthiazide 25 MG Oral Tablet	PSN	518be80a-9751-51b8-e054-00144ff88e88	3
310798	hydrochlorothiazide 25 MG Oral Tablet	SCD	518be80a-9751-51b8-e054-00144ff88e88	3
310798	HCTZ 25 MG Oral Tablet	SY	518be80a-9751-51b8-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68071-3238-1	68071323801	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrochlorothiazide Tablets USP	NuCare Pharmaceuticals, Inc.	2023-02-28	HUMAN PRESCRIPTION DRUG LABEL	3