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 4 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	42542233-b992-4953-87ec-5095b196d61b	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	89d367b1-de04-4970-9967-27a1c7711c0f	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	1dc47186-3ecf-456f-b6d6-ba0f75c2504b	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	67bedecc-f758-4bc6-82c5-7d428cbbbd9b	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d7d0867a-748e-4960-851f-ad764e07f774	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Oxford Pharmaceuticals, LLC	afbb9a0e-c22f-4133-8015-b4b2ab4d32e6	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	73bc116a-2964-4acc-9ef0-0a3f66268913	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	8d5a9196-5f1d-2d83-e053-2a95a90a6036	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	13ed002f-c5bb-401c-891a-70b70cbd8fb6	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	33f3b980-b339-4dbf-99bd-05588c2a298c	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	c59c4230-7cea-4259-9f2f-6a568716fedf	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	02a481cb-ad80-41bb-82d3-c237b00ed8d7	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	1570f1ad-8372-477f-89c3-8c9ce01e27d1	2025-05-07	Warnings, Adverse reactions	Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b0	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	fea5a353-9b13-9b87-e053-6394a90a627d	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	852c6f3f-d3f5-0d99-e053-2991aa0aa9c3	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	4c1a2fb9-133d-4bd5-a336-e47d54f22c97	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Redpharm drug	fa1c0b92-4360-bcfd-e053-6394a90a955a	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Direct_Rx	05156717-fe1b-22f1-e063-6394a90a3d10	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	93f6a018-8b3d-4f40-be25-902daec19aea	2025-01-21	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