Valsartan

Product NDC: 50268-747
11-digit product format: 502680747
Labeler code: 50268
Product ID: 50268-747_2b4bed38-a3f8-00ef-e063-6394a90afba8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA203311
Marketing category: ANDA
Marketing start: 2023-10-24
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: 2026-12-31
Current FDA listing: Yes

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	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 · 168 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
2026-08-18 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203311-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

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

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 · 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
0878f27e-5368-c93f-e063-6394a90a1086	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-747-11	Valsartan	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
50268-747-15	Valsartan	50 in 1 BOX	TABLET, FILM COATED	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-747-11	EA - Each	50268-747	4cc122b4-dfee-45aa-a695-b4ca03bbf364	1	2023-12-05
50268-747-15	EA - Each	50268-747	3a61c92e-0bf6-43b2-abc3-3666ca3a2d1a	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-747	VALSARTAN TABLET, FILM COATED [AVPAK]	2	Current NDC, 2 package rows	20250112_0878f27e-5368-c93f-e063-6394a90a1086.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 · 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
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 ndc (product): 50268-747
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349201	valsartan 160 MG Oral Tablet	PSN	0878f27e-5368-c93f-e063-6394a90a1086	2
349200	valsartan 320 MG Oral Tablet	PSN	0878f27e-5368-c93f-e063-6394a90a1086	2
349483	valsartan 40 MG Oral Tablet	PSN	0878f27e-5368-c93f-e063-6394a90a1086	2
349199	valsartan 80 MG Oral Tablet	PSN	0878f27e-5368-c93f-e063-6394a90a1086	2
349201	valsartan 160 MG Oral Tablet	SCD	0878f27e-5368-c93f-e063-6394a90a1086	2
349200	valsartan 320 MG Oral Tablet	SCD	0878f27e-5368-c93f-e063-6394a90a1086	2
349483	valsartan 40 MG Oral Tablet	SCD	0878f27e-5368-c93f-e063-6394a90a1086	2
349199	valsartan 80 MG Oral Tablet	SCD	0878f27e-5368-c93f-e063-6394a90a1086	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-747-11	50268074711	1 in 1 BLISTER PACK					Historical
50268-747-15	50268074715	50 BLISTER PACK in 1 BOX (50268-747-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-747-11)	50 blister pack	2023-10-24	No	No	Current