Valsartan

Product NDC: 50436-2168
11-digit product format: 504362168
Labeler code: 50436
Product ID: 50436-2168_8b80e7d4-5e8b-4813-a9d9-eede01e74af6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA090642
Marketing category: ANDA
Marketing start: 2015-01-05
Marketing end: 0000-00-00
Substance: VALSARTAN
Active strength: 80 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50436-2168		I	Inactivated by FDA		2026-08-17
excluded package	package	50436-2168	50436-2168-1	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 1 · 38 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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`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	50436-2168-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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	Approval date
A090642-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	2015-01-05
A090642-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	2015-01-05
A090642-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	2015-01-05
A090642-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	2015-01-05

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090642-001	VALSARTAN	40MG	TABLET / ORAL	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090642-002	VALSARTAN	80MG	TABLET / ORAL	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090642-003	VALSARTAN	160MG	TABLET / ORAL	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090642-004	VALSARTAN	320MG	TABLET / ORAL	2015-01-05	`d8e5a09893c0…`

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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
50436-2168-1	2021-01-29	C162847	48780-1	ba0f9c33-37ad-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS . VALSARTAN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-2168-1	Valsartan	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-2168	VALSARTAN TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 1 package rows	20180612_8dd697b1-e8e1-42aa-b5d0-776de580f700.zip

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
349199	valsartan 80 MG Oral Tablet	PSN	8dd697b1-e8e1-42aa-b5d0-776de580f700	2
349199	valsartan 80 MG Oral Tablet	SCD	8dd697b1-e8e1-42aa-b5d0-776de580f700	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-2168-1	50436216801	30 in 1 BOTTLE	Historical