Diovan

Product NDC: 67544-404
11-digit product format: 675440404
Labeler code: 67544
Product ID: 67544-404_948ffea7-be2c-4b21-9880-8e27af9a4090
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021283
Marketing category: NDA
Marketing start: 2001-07-01
Marketing end: 0000-00-00
Substance: VALSARTAN
Active strength: 160 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-404		I	Inactivated by FDA	2026-08-17
excluded package	package	67544-404	67544-404-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-404	67544-404-79	I	Inactivated by FDA	2026-08-17

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 · 63 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	67544-404-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-404-30	`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	67544-404-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-404-30	`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	67544-404-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-404-30	`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	67544-404-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-404-30	`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	67544-404-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-404-30	`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	67544-404-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-404-30	`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	67544-404-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-404-30	`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	67544-404-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-404-30	`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	67544-404-79	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-404-30	`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	67544-404-79	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67544-404-30	`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	67544-404-79	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67544-404-30	`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	67544-404-79	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67544-404-30	`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	67544-404-79	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67544-404-30	`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	67544-404-79	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67544-404-30	`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	67544-404-79	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67544-404-30	`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	67544-404-79	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67544-404-30	`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	67544-404-79	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67544-404-30	`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	67544-404-79	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67544-404-30	`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	67544-404-79	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67544-404-30	`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	67544-404-79	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67544-404-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021283-001	DIOVAN	VALSARTAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-002	DIOVAN	VALSARTAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-003	DIOVAN	VALSARTAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18
N021283-004	DIOVAN	VALSARTAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021283-001	AB
N021283-002	AB
N021283-003	AB
N021283-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021283-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021283-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	AB	1	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	NPP	2024-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	NPP	2024-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	NPP	2024-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	NPP	2024-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-001	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-002	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-004	NPP	2024-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-001	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-002	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-004	NPP	2024-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-001	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-002	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-004	NPP	2024-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021283-001	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-002	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-004	NPP	2024-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-001	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-002	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-004	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021283-001	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-002	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-004	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021283-001	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-002	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-004	NPP	2024-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021283-001	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-002	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-004	NPP	2024-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021283-001	NPP	2024-04-19	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
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
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
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
67544-404-30	2020-01-31	C162847	48780-1	9d75b9cf-f7fd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996
67544-404-79	2020-01-31	C162847	48780-1	9d75b9cf-f7fd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Diovan safely and effectively. See full prescribing information for Diovan. Diovan (valsartan) Tablets Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67544-404-30	Diovan	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
67544-404-79	Diovan	6030 in 1 BOTTLE, PLASTIC	TABLET	6030		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-404-30	EA - Each	67544-404	14c25e71-6664-4bba-bb34-c95c4cc61a17	1	2014-02-04
67544-404-79	EA - Each	67544-404	c8ee86e7-84eb-45a6-9adf-607bdc712c7a	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-404	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 2 package rows	20140509_c6488119-6547-4abd-bc15-a809b6107d4f.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	VALSARTAN	Novartis Pharmaceuticals Corporation	5ddba454-f3e6-43c2-a7a6-58365d297213	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021283 application number: NDA021283

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351762	Diovan 160 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	Diovan 80 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
349201	valsartan 160 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
349199	valsartan 80 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
351762	valsartan 160 MG Oral Tablet [Diovan]	SBD	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	valsartan 80 MG Oral Tablet [Diovan]	SBD	c6488119-6547-4abd-bc15-a809b6107d4f	2
349201	valsartan 160 MG Oral Tablet	SCD	c6488119-6547-4abd-bc15-a809b6107d4f	2
349199	valsartan 80 MG Oral Tablet	SCD	c6488119-6547-4abd-bc15-a809b6107d4f	2
351762	Diovan 160 MG Oral Tablet	SY	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	Diovan 80 MG Oral Tablet	SY	c6488119-6547-4abd-bc15-a809b6107d4f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-404-30	67544040430	30 in 1 BOTTLE, PLASTIC	Historical
67544-404-79	67544040479	6030 in 1 BOTTLE, PLASTIC	Historical