Valsartan

Product NDC: 67046-1596
Requested package NDC: 67046-1596-3
11-digit product format: 670461596
Labeler code: 67046
Product ID: 67046-1596_3eee86c0-9596-73a2-e063-6394a90a45fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA203311
Marketing category: ANDA
Marketing start: 2025-09-16
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
A203311-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05
A203311-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05
A203311-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05
A203311-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203311-001	AB
A203311-002	AB
A203311-003	AB
A203311-004	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	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`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	A203311-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203311-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203311-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203311-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203311-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203311-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203311-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203311-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203311-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203311-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203311-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203311-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203311-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203311-004	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
3eee9505-ebba-76e3-e063-6294a90acd6e	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Northwind Health Company, LLC	04b3301f-e054-ed5d-e063-6294a90a819c	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Bryant Ranch Prepack	6e9c4c57-e2c9-461b-9c09-669d3ada4c1a	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Bryant Ranch Prepack	c12db287-786c-47ae-a1f3-df04ddfd2a70	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Bryant Ranch Prepack	b3880f58-ce15-4701-84aa-8eb185cf43e2	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Bryant Ranch Prepack	7b523502-62b3-425e-960b-f0a58919d3ec	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	A-S Medication Solutions	0925a24f-6a72-4c77-b4e6-0a8f5b12c8d0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	d6e84105-9394-4ef0-928c-20d07d3fbaa9	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Northwind Health Company, LLC	f756009f-f04f-6518-e053-6294a90a79ed	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Coupler LLC	3eee9505-ebba-76e3-e063-6294a90acd6e	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311 ndc (package): 67046-1596-3 ndc (product): 67046-1596 ndc11 (package): 67046159603
Valsartan	VALSARTAN	Coupler LLC	3dfe5407-96a6-d2f4-e063-6294a90aa810	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Proficient Rx LP	f59f71d3-c143-43e5-ac22-0b1d741f4a81	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	Camber Pharmaceuticals, Inc.	0ff36e83-b307-42db-a2ab-bae3f6805c20	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	AvPAK	0878f27e-5368-c93f-e063-6394a90a1086	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	A-S Medication Solutions	688b5c82-2eba-445c-869e-60609f5db86a	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311
Valsartan	VALSARTAN	A-S Medication Solutions	506ab3dd-c5eb-4755-ad10-bc116f4443c7	2023-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203311 application number: ANDA203311

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	Marketing start	Sample	Exclude flag	Status
67046-1596-3	67046159603	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1596-3)	2025-09-16	No	No	Current