Application 011835

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	HYDRODIURIL	HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	HYDRODIURIL	HYDROCHLOROTHIAZIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	HYDRODIURIL	HYDROCHLOROTHIAZIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	RLD / RS
N011835-003	HYDRODIURIL	HYDROCHLOROTHIAZIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011835-006	HYDRODIURIL	HYDROCHLOROTHIAZIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011835-007	HYDRODIURIL	HYDROCHLOROTHIAZIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011835-006	HYDRODIURIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011835-007	HYDRODIURIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011835-003	HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.