HYDROCHLOROTHIAZIDE

Product NDC: 53401-038
11-digit product format: 534010038
Labeler code: 53401
Product ID: 53401-038_5ba2321c-931b-f6f7-e063-6294a90a513c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCHLOROTHIAZIDE
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040702
Marketing category: ANDA
Marketing start: 2017-05-10
Substance: HYDROCHLOROTHIAZIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040702-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16
A040702-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16
A040702-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040702-001	AB
A040702-002	AB
A040702-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040702-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040702-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2017-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040702-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-03-16	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A040702-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040702-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040702-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040702-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040702-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040702-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040702-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040702-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040702-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040702-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040702-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040702-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040702-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040702-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040702-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040702-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040702-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040702-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040702-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040702-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040702-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040702-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040702-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040702-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040702-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040702-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040702-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040702-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040702-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040702-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040702-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040702-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040702-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040702-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040702-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040702-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040702-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040702-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040702-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040702-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: HYDROCHLOROTHIAZIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCHLOROTHIAZIDE	12.5 mg/1

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	03b7e52e-0003-47c3-af12-93ef00800b37	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	a85f69f5-ba97-478d-e053-2a95a90a0a97	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Leading Pharma, LLC	8c868894-667e-4a51-906a-838d63e420ba	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	099496f1-4e2d-8d21-e063-6294a90af695	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f331769a-ff11-6c68-e053-2a95a90a493b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f9faec8a-2b71-47bb-a296-48ecbce9af50	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	93f6a018-8b3d-4f40-be25-902daec19aea	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4c1a92c0-b491-4ae9-8bd0-029beb2b13c6	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	1e02787f-ccb5-abc2-e063-6294a90af7c3	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	1884db5f-72b5-6b0c-e063-6394a90a0e49	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	6be05675-c4b4-4e1e-9047-044a7fc7cef6	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	e8ca7334-4b58-4f4b-bf36-0ab47b60ff7c	2020-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	ec70ea28-a219-45d1-9d5b-6a79c7ef4987	2020-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	2febae4f-836e-4935-bd06-3495f87b3b82	2017-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040702 application number: ANDA040702

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	Sample	Exclude flag	Status
53401-038-53	53401003853	60 TABLET in 1 BOTTLE (53401-038-53)	60 tablet	2026-09-16	No	No	Current
53401-038-60	53401003860	90 TABLET in 1 BOTTLE (53401-038-60)	90 tablet	2026-09-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2026-09-16	HUMAN PRESCRIPTION DRUG LABEL	1