Valsartan

Product NDC: 53401-029
11-digit product format: 534010029
Labeler code: 53401
Product ID: 53401-029_59d3da9b-42dd-e73e-e063-6294a90aed7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204011
Marketing category: ANDA
Marketing start: 2020-06-23
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: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	80 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349199	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
59d3db05-2d63-9dbf-e063-6394a90a8dd3	Available on FDA.report

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 ndc (product): 53401-029
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53401-029-81	53401002981	1080 TABLET in 1 BOTTLE (53401-029-81)	1080 tablet	2026-08-24	No	No	Current