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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A084878-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084878-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2006-07-12	`84e616aacf4f…`
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…`

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 5 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	DIRECT RX	cbe5e01e-67ca-f8a2-e053-2995a90a0d15	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Quality Care Products LLC	a2de8e26-ef5a-41c7-888b-990629b11145	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Lake Erie Medical DBA Quality Care Products LLC	9e6a0c83-1494-44ca-90e0-3f43fa8ec746	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5f2e72cc-073d-4bb5-95fe-53d4060127ec	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8242c1de-f482-4a85-b977-610e71fa4904	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Rising Pharma Holdings, Inc.	33f9c3ae-108d-469e-af6c-8be3b0f83139	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	3e35fb03-9173-6731-e054-00144ff8d46c	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4c1a92c0-b491-4ae9-8bd0-029beb2b13c6	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	1e02787f-ccb5-abc2-e063-6294a90af7c3	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	53fe1730-a803-26b2-e054-00144ff88e88	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	e2270db4-2930-4ec5-ac96-2b4542aed367	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	e31bd548-29ae-419a-831a-80ebb26e042f	2024-06-26	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	01f1f478-5493-439f-9b99-f4f82023781c	2024-06-26	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	a111cb8f-a100-a05d-e053-2995a90a020c	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	6a11a458-dc69-40ba-a58a-649733e0e8ab	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	1884db5f-72b5-6b0c-e063-6394a90a0e49	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	98a58b54-bcf2-4726-800a-facf48d9155f	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	39d4dbd3-8f24-4898-a240-e94e06fa229a	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	cb7712f3-9a0b-442d-859d-8be5e6e2529a	2024-03-29	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	2e4eee3a-fe0c-44aa-8ff1-b14b07a0c5bc	2024-03-27	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 · 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