Application 040807

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	12.5MG	No	No
002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG	No	No
003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG	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	Approval date
A040807-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	2007-07-20
A040807-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	2007-07-20
A040807-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	2007-07-20

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 · 129 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	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2007-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2007-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2007-07-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040807-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040807-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040807-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040807-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040807-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040807-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040807-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040807-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040807-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040807-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040807-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040807-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040807-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040807-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040807-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040807-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040807-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040807-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040807-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040807-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040807-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040807-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040807-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040807-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040807-001	AB	1	`782e0a99824c…`

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 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ff557069-f177-4e2e-91f4-675a033e2739	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	c8de63da-b6c0-42f0-9d47-e273fe93adb3	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Coupler LLC	4ee35bcf-1eb0-1cca-e063-6294a90adeed	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	babb1b20-fe82-40ba-8e7a-0c56fe433b4a	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	45316037-52ec-438f-8780-b2e983fef3f5	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	c2db7e27-952f-c3f6-e053-2995a90af7c1	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	c2d993ff-b11b-7a62-e053-2995a90a0b00	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Westminster Pharmaceuticals, LLC	0fc94bc2-fa38-439a-a609-1b4130cdacb1	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	2ec371a5-18ba-4ce2-9725-7f99bb73454a	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Legacy Pharmaceutical Packaging, LLC	1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	2026-03-05	Warnings	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	ScieGen Pharmaceuticals Inc	911a18c1-120a-46b3-b7a8-25eb37843473	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	088cb67f-3eaa-4e78-9fbe-ad2d6b7c5707	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f1f99065-04d2-48ac-b25d-9595237c869c	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	0dbc5ebb-99ab-428d-b9b3-cd7a68dd948a	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	686a5743-adc9-4729-9dbf-5cbc2c23897a	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	AvPAK	ef56450d-86d3-2654-e053-2995a90a142c	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	c8c79657-a09a-bdb6-e053-2995a90ab673	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	57a2f9bd-8ca5-437e-b911-5207f94cc6ba	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-047	Hydrochlorothiazide	Hydrochlorothiazide	Blenheim Pharmacal, Inc.	ANDA	Current
10544-136	Hydrochlorothiazide	Hydrochlorothiazide	Blenheim Pharmacal, Inc.	ANDA	Current
23155-046	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-046	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-047	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-047	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-137	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-137	Hydrochlorothiazide	Hydrochlorothiazide	Heritage Pharmaceuticals Inc.	ANDA	Current
42254-132	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
50436-3919	Hydrochlorothiazide	Hydrochlorothiazide	Unit Dose Services	ANDA	Current
51655-126	Hydrochlorothiazide	Hydrochlorothiazide	Northwind Pharmaceuticals, LLC	ANDA	Current
52959-132	Hydrochlorothiazide	Hydrochlorothiazide	H.J. Harkins Company, Inc.	ANDA	Current
63187-074	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
63187-074	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	ANDA	Current
64725-0047	Hydrochlorothiazide	Hydrochlorothiazide	TYA Pharmaceuticals	ANDA	Current
67046-277	Hydrochlorothiazide	Hydrochlorothiazide	Contract Pharmacy Services-PA	ANDA	Current
68788-9401	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9401	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals, Inc.	ANDA	Current