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 3 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	ab8115a0-e96f-7aee-e053-2995a90a6ec0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f3191ca2-4dbc-01f5-e053-2a95a90a572c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	e3afa83d-c79c-848a-e053-2a95a90ac922	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f331769a-ff11-6c68-e053-2a95a90a493b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f2f3b60a-bffe-2675-e053-2995a90ae96e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f7091c54-0984-7f6e-e053-6394a90afb4d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f68d211d-d802-6c78-e053-2995a90a90d7	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	076017ce-8aad-1336-e063-6394a90a76b5	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	f9faec8a-2b71-47bb-a296-48ecbce9af50	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	c9c44c37-bb49-4364-9293-3c8fd51b759e	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
INZIRQO	HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	41aaea48-6c1b-42c8-a96f-5923d49dc934	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	9cd5d16e-3db7-4b25-847d-6de91543463b	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Chartwell RX, LLC	4e43dd27-3f4b-4205-a26e-6ecaa8281347	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma Inc	578f74ea-53d1-4c44-b872-66033292abe0	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	5bacc909-6b02-4815-85ef-55fd25b1b1f7	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	QPharma Inc	f795db5e-d5ef-4a20-e053-6394a90a7fda	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	0937d511-4d5e-4aba-bfae-92094c67bcf4	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	c182b6a9-1a31-45ee-9cea-a557c99f5db7	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ef8a7dee-3704-4c62-8981-f8adfb47f5d0	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	67c48f86-f412-4957-8e15-aec89e07d295	2025-11-18	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