Application 040907

Type: ANDA
Sponsor: UNICHEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG	No	No
002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG	No	No
003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 92 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
2026-09-14 22:38:34	2026-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040907-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-003	AB	1	`84e616aacf4f…`
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…`

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	9dd2f58b-d143-4d0c-a298-6d9390e6187a	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Exelan Pharmaceuticals Inc.	b5a1b38c-0433-4649-a8b0-f72db0a96c45	2018-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907 ndc (product): 76282-154 ndc (product): 76282-155

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0065	Hydrochlorothiazide	Hydrochlorothiazide	KAISER FOUNDATION HOSPITALS	ANDA	Current
10544-900	Hydrochlorothiazide	Hydrochlorothiazide	Blenheim Pharmacal, Inc.	ANDA	Current
29300-128	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-128	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-128	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-128	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-129	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-129	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-129	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-129	Hydrochlorothiazide	Hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
42708-079	Hydrochlorothiazide	Hydrochlorothiazide	QPharma Inc	ANDA	Current
42708-079	Hydrochlorothiazide	Hydrochlorothiazide	QPharma Inc	ANDA	Current
50090-0140	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-0141	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-0141	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-0141	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-5057	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-5057	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
55700-006	Hydrochlorothiazide	Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-006	Hydrochlorothiazide	Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-006	Hydrochlorothiazide	Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-006	Hydrochlorothiazide	Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-006	Hydrochlorothiazide	Hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0123	Hydrochlorothiazide	Hydrochlorothiazide	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0123	Hydrochlorothiazide	Hydrochlorothiazide	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0123	Hydrochlorothiazide	Hydrochlorothiazide	Clinical Solutions Wholesale, LLC	ANDA	Current
60760-315	Hydrochlorothiazide	Hydrochlorothiazide	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	DIRECT RX	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-293	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
68071-3238	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4807	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4807	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4933	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4933	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9965	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9965	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9965	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9965	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-789	Hydrochlorothiazide	Hydrochlorothiazide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-789	Hydrochlorothiazide	Hydrochlorothiazide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-419	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-419	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71335-0652	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0652	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0652	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-1976	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-1976	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71610-323	Hydrochlorothiazide	Hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-154	Hydrochlorothiazide	Hydrochlorothiazide	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-155	Hydrochlorothiazide	Hydrochlorothiazide	Exelan Pharmaceuticals Inc.	ANDA	Current