Valsartan

Product NDC: 65162-837
11-digit product format: 651620837
Labeler code: 65162
Product ID: 65162-837_ce6ac5f2-be9c-461a-b749-5a2e24552878
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA204011
Marketing category: ANDA
Marketing start: 2016-01-27
Substance: VALSARTAN
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A204011-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11
A204011-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11
A204011-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11
A204011-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204011-001	AB
A204011-002	AB
A204011-003	AB
A204011-004	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 · 172 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	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A204011-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204011-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204011-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204011-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204011-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204011-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204011-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204011-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204011-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204011-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204011-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204011-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204011-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204011-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Valsartan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80M03YXJ7I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349199	Internal RxNorm lookup
349200	Internal RxNorm lookup
349201	Internal RxNorm lookup
349483	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4a5df78-157b-4996-845c-235234250f11	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-837-03	Valsartan	30 in 1 BOTTLE	TABLET	30	22
65162-837-06	Valsartan	60 in 1 BOTTLE	TABLET	60	22
65162-837-50	Valsartan	500 in 1 BOTTLE	TABLET	500	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-837-03	EA - Each	65162-837	cd2927bd-0df8-49dd-ac81-9c7f19b1aefc	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-837	VALSARTAN TABLET [AMNEAL PHARMACEUTICALS LLC]	22	Current NDC, Legacy NDC, 3 package rows	20241031_f4a5df78-157b-4996-845c-235234250f11.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	5a816ea6-2645-bd6e-e063-6294a90a908b	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011
Valsartan	VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	59d3db05-2d63-9dbf-e063-6394a90a8dd3	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011
Valsartan	VALSARTAN	AvKARE	a8c61488-4219-dfcb-e053-2a95a90a98a4	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011
Valsartan	VALSARTAN	Amneal Pharmaceuticals of New York LLC	f13587f8-76cb-49ad-9291-5907249d6b8e	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011
Valsartan	VALSARTAN	Amneal Pharmaceuticals LLC	f4a5df78-157b-4996-845c-235234250f11	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204011 application number: ANDA204011 ndc (product): 65162-837

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
349201	valsartan 160 MG Oral Tablet	PSN	f4a5df78-157b-4996-845c-235234250f11	22
349200	valsartan 320 MG Oral Tablet	PSN	f4a5df78-157b-4996-845c-235234250f11	22
349483	valsartan 40 MG Oral Tablet	PSN	f4a5df78-157b-4996-845c-235234250f11	22
349199	valsartan 80 MG Oral Tablet	PSN	f4a5df78-157b-4996-845c-235234250f11	22
349201	valsartan 160 MG Oral Tablet	SCD	f4a5df78-157b-4996-845c-235234250f11	22
349200	valsartan 320 MG Oral Tablet	SCD	f4a5df78-157b-4996-845c-235234250f11	22
349483	valsartan 40 MG Oral Tablet	SCD	f4a5df78-157b-4996-845c-235234250f11	22
349199	valsartan 80 MG Oral Tablet	SCD	f4a5df78-157b-4996-845c-235234250f11	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-837-03	65162083703	30 TABLET in 1 BOTTLE (65162-837-03)	30 tablet	2016-01-27	0000-00-00	No	No	Current
65162-837-06	65162083706	60 TABLET in 1 BOTTLE (65162-837-06)	60 tablet	2016-01-27	0000-00-00	No	No	Current
65162-837-50	65162083750	500 TABLET in 1 BOTTLE (65162-837-50)	500 tablet	2016-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valsartan	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	22