Application 078164

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A078164-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB		2007-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078164-001	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	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078164-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2007-09-18	`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	A078164-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078164-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078164-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078164-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078164-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078164-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078164-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078164-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078164-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078164-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078164-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078164-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078164-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078164-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078164-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078164-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078164-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078164-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078164-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078164-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078164-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078164-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078164-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078164-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078164-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078164-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078164-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078164-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078164-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078164-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078164-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078164-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078164-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078164-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078164-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078164-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078164-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078164-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078164-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078164-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b0	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078164 application number: ANDA078164
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8242c1de-f482-4a85-b977-610e71fa4904	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078164 application number: ANDA078164 ndc (product): 71335-0770
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Rising Pharma Holdings, Inc.	33f9c3ae-108d-469e-af6c-8be3b0f83139	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078164 application number: ANDA078164 ndc (product): 57237-002
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	e31bd548-29ae-419a-831a-80ebb26e042f	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078164 application number: ANDA078164 ndc (product): 65862-113

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5672	Hydrochlorothiazide	Hydrochlorothiazide	A-S Medication Solutions	ANDA	Current
53808-0265	Hydrochlorothiazide	Hydrochlorothiazide	State of Florida DOH Central Pharmacy	ANDA	Current
57237-002	Hydrochlorothiazide	Hydrochlorothiazide	Rising Health, LLC	ANDA	Current
57237-002	Hydrochlorothiazide	Hydrochlorothiazide	Rising Health, LLC	ANDA	Current
57237-002	Hydrochlorothiazide	Hydrochlorothiazide	Rising Health, LLC	ANDA	Current
65862-113	Hydrochlorothiazide	Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-113	Hydrochlorothiazide	Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-113	Hydrochlorothiazide	Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-113	Hydrochlorothiazide	Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-113	Hydrochlorothiazide	Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
68071-4361	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4361	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4758	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,In	ANDA	Current
68071-4758	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4758	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7475	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7475	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-321	Hydrochlorothiazide	Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-321	Hydrochlorothiazide	Hydrochlorothiazide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0770	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0770	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
71335-0770	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current