Application 084878

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084878-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982
A084878-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A084878-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A084878-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084878-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084878-001	AB	1	`ea99ee380514…`

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1256	Hydrochlorothiazide	Hydrochlorothiazide	West-ward Pharmaceutical Corp	ANDA	Current
0143-1257	Hydrochlorothiazide	Hydrochlorothiazide	West-ward Pharmaceutical Corp	ANDA	Current
21695-538	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
21695-539	Hydrochlorothiazide	Hydrochlorothiazide	Rebel Distributors Corp	ANDA	Current
53808-0266	Hydrochlorothiazide	Hydrochlorothiazide	State of Florida DOH Central Pharmacy	ANDA	Current
55289-136	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
67046-271	Hydrochlorothiazide	Hydrochlorothiazide	Contract Pharmacy Services-PA	ANDA	Current
67046-272	Hydrochlorothiazide	Hydrochlorothiazide	Contract Pharmacy Services-PA	ANDA	Current