HYDROCHLOROTHIAZIDE

Product NDC: 68788-7648
11-digit product format: 687887648
Labeler code: 68788
Product ID: 68788-7648_bc1e8a60-3338-40d5-bfc7-9721f01e3cb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA085182
Marketing category: ANDA
Marketing start: 2020-04-17
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7648		D	Discontinued by firm	2026-08-11
excluded package	package	68788-7648	68788-7648-0	D	Discontinued by firm	2026-08-11
excluded package	package	68788-7648	68788-7648-1	D	Discontinued by firm	2026-08-11
excluded package	package	68788-7648	68788-7648-3	D	Discontinued by firm	2026-08-11
excluded package	package	68788-7648	68788-7648-6	D	Discontinued by firm	2026-08-11
excluded package	package	68788-7648	68788-7648-9	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7648-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7648-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7648-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7648-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7648-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7648-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7648-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7648-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7648-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7648-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7648-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7648-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7648-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7648-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7648-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7648-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7648-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7648-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7648-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7648-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7648-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7648-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7648-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7648-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7648-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7648-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7648-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7648-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7648-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7648-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7648-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7648-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7648-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7648-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7648-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7648-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7648-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7648-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7648-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7648-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7648-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7648-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7648-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7648-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7648-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7648-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7648-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7648-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7648-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7648-0	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
A085182-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982
A085182-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982
A085182-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A085182-001	AB
A085182-002	AB
A085182-003	AB

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 · 104 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
2026-02-19 14:30 UTC	2026-02	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2023-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085182-001	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085182-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085182-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085182-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085182-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085182-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085182-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085182-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085182-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085182-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085182-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085182-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085182-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085182-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085182-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085182-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085182-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085182-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085182-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085182-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085182-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7648-0	EA - Each	68788-7648	6e88c1cc-bc40-4395-a00b-f42103c41d76	1	2020-06-05
68788-7648-1	EA - Each	68788-7648	869deb4a-83fa-4d5e-9838-54ddf7624b18	1	2020-06-05
68788-7648-3	EA - Each	68788-7648	c8008715-7734-459f-b1f6-38221184007b	1	2020-06-05
68788-7648-6	EA - Each	68788-7648	833f7efd-ca1d-41f7-8f8c-d1cf3468b032	1	2020-06-05
68788-7648-9	EA - Each	68788-7648	ebc59d51-9e22-43a1-be09-c3083cdc2caa	1	2020-06-05

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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	31a3d1cb-0f52-4818-965d-7584374bb23e	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	5ab641d8-cd22-4368-8070-18487dd801eb	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	686a5743-adc9-4729-9dbf-5cbc2c23897a	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	c8c79657-a09a-bdb6-e053-2995a90ab673	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	076017ce-8aad-1336-e063-6394a90a76b5	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Chartwell RX, LLC	4e43dd27-3f4b-4205-a26e-6ecaa8281347	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	QPharma Inc	f795db5e-d5ef-4a20-e053-6394a90a7fda	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	1fad059f-f030-4dd8-b02a-bf3e775d37d2	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	67c48f86-f412-4957-8e15-aec89e07d295	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	42542233-b992-4953-87ec-5095b196d61b	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	c59c4230-7cea-4259-9f2f-6a568716fedf	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	1570f1ad-8372-477f-89c3-8c9ce01e27d1	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	a111cb8f-a100-a05d-e053-2995a90a020c	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5605f105-f7ec-473f-8beb-9e8955e8e26e	2023-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	Proficient Rx LP	3464be28-5bab-4642-9d9b-8b425822dd07	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085182 application number: ANDA085182

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7648-0	68788764800	100 TABLET in 1 BOTTLE (68788-7648-0)	100 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7648-1	68788764801	15 TABLET in 1 BOTTLE (68788-7648-1)	15 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7648-3	68788764803	30 TABLET in 1 BOTTLE (68788-7648-3)	30 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7648-6	68788764806	60 TABLET in 1 BOTTLE (68788-7648-6)	60 tablet	2020-04-17	0000-00-00	No	No	Current
68788-7648-9	68788764809	90 TABLET in 1 BOTTLE (68788-7648-9)	90 tablet	2020-04-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS, USP Rx only	Preferred Pharmaceuticals, Inc.	2022-12-12	HUMAN PRESCRIPTION DRUG LABEL	3