VALSARTAN AND HYDROCHLOROTHIAZIDE

Product NDC: 70518-0607
11-digit product format: 705180607
Labeler code: 70518
Product ID: 70518-0607_53b161d4-eae9-3494-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA206083
Marketing category: ANDA
Marketing start: 2017-07-06
Marketing end: 0000-00-00
Substance: VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 160 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-0607		D	Discontinued by firm		2026-10-05
excluded package	package	70518-0607	70518-0607-0	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 1 · 26 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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	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	70518-0607-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0607-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0607-0	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0607-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	70518-0607-0	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	TE codes	Approval date
A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08
A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08
A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08
A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	2016-02-08
A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	2016-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A206083-001	AB
A206083-002	AB
A206083-003	AB
A206083-004	AB
A206083-005	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 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	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2016-02-08	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206083-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206083-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206083-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206083-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206083-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206083-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206083-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206083-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206083-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-0607-0	2020-04-07	C162847	48780-1	9d75b9d0-3295-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE. VALSARTAN AND HYDROCHLOROTHIAZIDE (valsartan and hydrochlorothiazide) TABLET, FILM COATED for ORAL use. Initial U.S. Approval: 1998
70518-0607-0	2020-01-31	C162847	48780-1	9d75b9d0-3295-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE. VALSARTAN AND HYDROCHLOROTHIAZIDE (valsartan and hydrochlorothiazide) TABLET, FILM COATED 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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	af46984c-cb58-4886-baa2-0ee075242c27	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	d09747f0-029e-4090-949b-e939948249b5	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	f8b0a8ab-4549-4553-a127-bf2c0291a4b1	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f1df0d1e-d418-4f6e-a04a-77b5d4000e2b	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	d55b2f01-5cd1-40bb-8d36-34b5b9081ddc	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	46addda8-f798-4207-b8fb-ea75c5903a36	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3f1321b2-cad7-47c7-863f-38aa7a8b3599	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	93833cf2-631b-4058-809d-16cc11b858c0	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b6dc0544-898e-41e3-bd18-5757ede4477d	2024-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	38d84a2b-3c83-44a0-97d8-3f64d6101732	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083
VALSARTAN AND HYDROCHLOROTHIAZIDE	VALSARTAN AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	3131809e-885a-42d3-b6ad-1b208fd3ba56	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206083 application number: ANDA206083

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