Valsartan and Hydrochlorothiazide

Product NDC: 57297-105
11-digit product format: 572970105
Labeler code: 57297
Product ID: 57297-105_a3f79bb0-6766-40fd-9817-4b84ec840930
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: LUPIN LIMITED
Application: ANDA078946
Marketing category: ANDA
Marketing start: 2013-03-21
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57297-105		D	Discontinued by firm	2026-10-05
excluded package	package	57297-105	57297-105-02	D	Discontinued by firm	2026-10-05
excluded package	package	57297-105	57297-105-03	D	Discontinued by firm	2026-10-05
excluded package	package	57297-105	57297-105-09	D	Discontinued by firm	2026-10-05
excluded package	package	57297-105	57297-105-11	D	Discontinued by firm	2026-10-05

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 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-105-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-105-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-105-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-105-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-105-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-105-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-105-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-105-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-105-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-105-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-105-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-105-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-105-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-105-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-105-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-105-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-105-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-105-09	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-105-11	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-105-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-105-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-105-09	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-105-11	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-105-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-105-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-105-09	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-105-11	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-105-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-105-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-105-09	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-105-11	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-105-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-105-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-105-09	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-105-11	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-105-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-105-09	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-105-11	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-105-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-105-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-105-09	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-105-11	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-105-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-105-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-105-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-105-11	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-105-03	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-105-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	2013-03-21
A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	2013-03-21
A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	2013-03-21
A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	2013-03-21
A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	2013-03-21

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL		2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL		2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL		2013-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL		2013-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL		2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL		2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL		2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL		2013-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL		2013-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 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	A078946-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078946-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078946-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078946-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078946-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078946-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078946-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078946-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078946-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078946-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078946-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078946-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078946-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078946-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078946-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078946-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078946-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078946-005	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57297-105-02	2024-12-19	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-03	2024-12-19	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-09	2024-12-19	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-11	2024-12-19	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-02	2020-01-31	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-03	2020-01-31	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-09	2020-01-31	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
57297-105-11	2020-01-31	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Lupin Pharmaceuticals, Inc.	d74a85de-5917-401a-b92d-6a95da5d30a6	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078946 application number: ANDA078946
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	be008c6a-6036-4abf-a3fc-450465c88d55	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078946 application number: ANDA078946

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN