valsartan

Product NDC: 72789-281
11-digit product format: 727890281
Labeler code: 72789
Product ID: 72789-281_31b9f72f-7610-ac2e-e063-6394a90a63de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA203536
Marketing category: ANDA
Marketing start: 2015-01-05
Substance: VALSARTAN
Active strength: 160 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 1.

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
A203536-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05
A203536-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05
A203536-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05
A203536-004	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
A203536-001	AB
A203536-002	AB
A203536-003	AB
A203536-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203536-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203536-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203536-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203536-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203536-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203536-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203536-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203536-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203536-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203536-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	160 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
349201	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
5afd7c3d-c66b-479c-bfd0-6c04658b157d	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	Strength	SPL version
72789-281-60	valsartan	60 in 1 BOTTLE, PLASTIC	TABLET	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-281-60	EA - Each	72789-281	20d8e34b-3611-4026-84f2-408744c3d67d	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-281	VALSARTAN TABLET [PD-RX PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20250403_5afd7c3d-c66b-479c-bfd0-6c04658b157d.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
valsartan	VALSARTAN	Northwind Health Company, LLC	db4801e5-6e0f-2cb3-e053-2995a90a709a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536
valsartan	VALSARTAN	PD-Rx Pharmaceuticals, Inc.	5afd7c3d-c66b-479c-bfd0-6c04658b157d	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 72789-281
valsartan	VALSARTAN	Jubilant Cadista Pharmacuticals Inc.	9402b022-5809-4251-dfef-54f6ef5723fe	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536
valsartan	VALSARTAN	A-S Medication Solutions	80987771-ccb4-4a9f-a395-0af4c2621e0a	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536
valsartan	VALSARTAN	A-S Medication Solutions	e352db8b-0485-492a-8734-0a415566d764	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536
valsartan	VALSARTAN	A-S Medication Solutions	9f5a400f-9cfc-4d25-a677-73cbb14375e2	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536

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	5afd7c3d-c66b-479c-bfd0-6c04658b157d	10
349201	valsartan 160 MG Oral Tablet	SCD	5afd7c3d-c66b-479c-bfd0-6c04658b157d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-281-60	72789028160	60 TABLET in 1 BOTTLE, PLASTIC (72789-281-60)	60 tablet	2022-10-11	0000-00-00	No	No	Current