Valsartan and Hydrochlorothiazide

Product NDC: 63629-4805
11-digit product format: 636294805
Labeler code: 63629
Product ID: 63629-4805_1089036d-f39e-4c21-ab63-523046cee88b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202519
Marketing category: ANDA
Marketing start: 2013-03-21
Marketing end: 0000-00-00
Substance: VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 320 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: No
Listing certified through: 2021-12-31
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	63629-4805		D	Discontinued by firm		2026-08-03
excluded package	package	63629-4805	63629-4805-1	D	Discontinued by firm		2026-08-03

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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	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	63629-4805-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4805-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A202519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21
A202519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21
A202519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21
A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	2013-03-21
A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	2013-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202519-001	AB
A202519-002	AB
A202519-003	AB
A202519-004	AB
A202519-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A202519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-001	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	A202519-002	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	A202519-003	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	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-001	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	A202519-002	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	A202519-003	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	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-001	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	A202519-002	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	A202519-003	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	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-001	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	A202519-002	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	A202519-003	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	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-001	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-002	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;160MG	TABLET / ORAL	AB	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-003	VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG	TABLET / ORAL	AB	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-004	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;160MG	TABLET / ORAL	AB	2013-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-005	VALSARTAN AND HYDROCHLOROTHIAZIDE	25MG;320MG	TABLET / ORAL	AB	2013-03-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A202519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202519-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202519-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202519-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202519-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202519-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202519-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202519-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202519-005	AB	1	`5bbf6a4d5a75…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-4805-1	2020-10-16	C162847	48780-1	9d75b9d0-51c1-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998
63629-4805-1	2020-01-31	C162847	48780-1	9d75b9d0-51c1-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS. VALSARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1998

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	c5bc7c55-b50c-4e61-ad1f-5ebb607c262f	2024-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202519 application number: ANDA202519
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	75b3f944-b4fc-40a5-a4e2-aec2fbab64b8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202519 application number: ANDA202519
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	411caa05-5eff-4285-a940-7f6d2429ba81	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202519 application number: ANDA202519
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	e1f94546-c71c-4175-9384-20238181e05f	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202519 application number: ANDA202519
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	1f6ab5e0-8320-4489-bed2-8c90c534e5ae	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202519 application number: ANDA202519

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4805-1	63629480501	1 TABLET, FILM COATED in 1 BOTTLE (63629-4805-1)	2016-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valsartan and Hydrochlorothiazide	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	1004