Application 090510

Type: ANDA
Sponsor: UNICHEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	CAPSULE;ORAL	12.5MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090510-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB		2010-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090510-001	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 2 · 42 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	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090510-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-01-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A090510-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090510-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090510-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090510-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090510-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090510-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090510-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090510-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090510-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090510-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090510-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090510-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090510-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090510-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090510-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090510-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090510-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090510-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090510-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090510-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090510-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090510-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090510-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090510-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090510-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090510-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090510-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090510-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090510-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090510-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090510-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090510-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090510-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090510-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090510-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090510-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090510-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090510-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090510-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090510-001	AB	1	`e64feba35796…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	e3afa83d-c79c-848a-e053-2a95a90ac922	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma Inc	578f74ea-53d1-4c44-b872-66033292abe0	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 42708-086
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	13ed002f-c5bb-401c-891a-70b70cbd8fb6	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 60687-683
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Quality Care Products LLC	a2de8e26-ef5a-41c7-888b-990629b11145	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 35356-807
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	6a11a458-dc69-40ba-a58a-649733e0e8ab	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 71335-0067
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	39d4dbd3-8f24-4898-a240-e94e06fa229a	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 50090-0724
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	cb7712f3-9a0b-442d-859d-8be5e6e2529a	2024-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 29300-130
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	98edae8a-99dc-4f26-a956-3ad58bf38a26	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090510 application number: ANDA090510 ndc (product): 71205-161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-130	hydrochlorothiazide	hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-130	hydrochlorothiazide	hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-130	hydrochlorothiazide	hydrochlorothiazide	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
35356-807	hydrochlorothiazide	hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-807	hydrochlorothiazide	hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-807	hydrochlorothiazide	hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-807	hydrochlorothiazide	hydrochlorothiazide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42708-086	hydrochlorothiazide	hydrochlorothiazide	QPharma Inc	ANDA	Current
42708-086	hydrochlorothiazide	hydrochlorothiazide	QPharma Inc	ANDA	Current
50090-0724	hydrochlorothiazide	hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-0724	hydrochlorothiazide	hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50090-0724	hydrochlorothiazide	hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
50436-0130	hydrochlorothiazide	hydrochlorothiazide	Unit Dose Services	ANDA	Current
53808-0961	hydrochlorothiazide	hydrochlorothiazide	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1016	hydrochlorothiazide	hydrochlorothiazide	State of Florida DOH Central Pharmacy	ANDA	Current
60687-683	hydrochlorothiazide	hydrochlorothiazide	American Health Packaging	ANDA	Current
61919-580	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	DIRECT RX	ANDA	Current
61919-580	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-580	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-580	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
61919-580	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Direct_Rx	ANDA	Current
64205-130	hydrochlorothiazide	hydrochlorothiazide	ReadyMeds	ANDA	Current
66116-473	Hydrochlorothiazide	Hydrochlorothiazide	MedVantx, Inc.	ANDA	Current
68071-1255	hydrochlorothiazide	hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
69189-0194	hydrochlorothiazide	hydrochlorothiazide	Avera McKennan Hospital	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-0335	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1676	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1676	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1676	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1676	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1676	hydrochlorothiazide	hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70934-158	hydrochlorothiazide	hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-158	hydrochlorothiazide	hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-158	hydrochlorothiazide	hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-161	hydrochlorothiazide	hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-161	hydrochlorothiazide	hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-161	hydrochlorothiazide	hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-161	hydrochlorothiazide	hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71205-161	hydrochlorothiazide	hydrochlorothiazide	Proficient Rx LP	ANDA	Current
71335-0067	hydrochlorothiazide	hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0067	hydrochlorothiazide	hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0067	hydrochlorothiazide	hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0067	hydrochlorothiazide	hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
75921-130	Hydrochlorothiazide	Hydrochlorothiazide	Life Line Home Care Services, Inc.	ANDA	Current