Diovan HCT

Product NDC: 68258-6056
11-digit product format: 682586056
Labeler code: 68258
Product ID: 68258-6056_5ce44a1d-f91e-4cd8-a51c-6993bbb9e56e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: NDA020818
Marketing category: NDA
Marketing start: 1998-03-06
Marketing end: 0000-00-00
Substance: VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 80 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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-6056		I	Inactivated by FDA		2026-08-03
excluded package	package	68258-6056	68258-6056-3	I	Inactivated by FDA		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 · 44 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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`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	68258-6056-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-6056-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-6056-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-6056-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-6056-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-6056-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-6056-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-6056-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-6056-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-6056-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-6056-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-6056-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-6056-3	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N020818-001	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-002	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-003	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17
N020818-004	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28
N020818-005	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020818-001	AB
N020818-002	AB
N020818-003	AB
N020818-004	AB
N020818-005	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`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	N020818-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	AB	1	`5bbf6a4d5a75…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-6056-3	2019-11-27	C162847	48780-1	9855d018-ee6d-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use Diovan HCT safely and effectively. See full prescribing information for Diovan HCT. Diovan HCT (valsartan and hydrochlorothiazide USP) Tablets Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-6056-3	Diovan HCT	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-6056	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20121011_7b7dd683-78d0-468e-b1c9-e5b212a19c9a.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diovan HCT	VALSARTAN AND HYDROCHLOROTHIAZIDE	Novartis Pharmaceuticals Corporation	d76a0419-05ee-437e-884c-65807aea9569	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020818 application number: NDA020818

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
809014	Diovan HCT 80 MG / 12.5 MG Oral Tablet	PSN	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	PSN	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
809014	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SBD	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
200284	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet	SCD	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
809014	Diovan HCT 80/12.5 (valsartan / HCTZ) Oral Tablet	SY	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
809014	Diovan HCT 80/12.5 Oral Tablet	SY	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	SY	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1
809014	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SY	7b7dd683-78d0-468e-b1c9-e5b212a19c9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-6056-3	68258605603	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diovan HCT	Dispensing Solutions, Inc. \| PSS World Medical Inc.	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	1