Valsartan

Product NDC: 51655-653
11-digit product format: 516550653
Labeler code: 51655
Product ID: 51655-653_4b81c300-9f11-6269-e063-6294a90adc2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA204821
Marketing category: ANDA
Marketing start: 2023-08-15
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 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
A204821-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09
A204821-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09
A204821-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09
A204821-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204821-001	AB
A204821-002	AB
A204821-003	AB
A204821-004	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	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204821-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-06-09	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A204821-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204821-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204821-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204821-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204821-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204821-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204821-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204821-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204821-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204821-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204821-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204821-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204821-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204821-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204821-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204821-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204821-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204821-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204821-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204821-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204821-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204821-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204821-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204821-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204821-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204821-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204821-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204821-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204821-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204821-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204821-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204821-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204821-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204821-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204821-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204821-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204821-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204821-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204821-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204821-004	AB	1	`bb7c543d1eb4…`

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
03af7d09-314a-fe85-e063-6294a90afa25	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	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
51655-653-52	Valsartan	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-653	VALSARTAN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20240127_03af7d09-314a-fe85-e063-6294a90afa25.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	A-S Medication Solutions	d9af6ba1-c760-4af6-b733-88e4892d4cb6	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Northwind Health Company, LLC	03af7d09-314a-fe85-e063-6294a90afa25	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821 ndc (product): 51655-653
Valsartan	VALSARTAN	Solco Healthcare US, LLC	26080940-bcd3-446d-9026-3ddfb58e281e	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	A-S Medication Solutions	2847db2a-fcc9-4776-875a-ba6d57d5ea8b	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	d9a16816-d4de-401a-8413-7233f4e541f8	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	e8fcd4c2-8baa-452a-b723-5cb3d8d203a9	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	4e160647-a08e-40e8-b566-3e97a09c616a	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Bryant Ranch Prepack	bcbd44f6-d49a-4a59-bba5-70fb843d1f59	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821
Valsartan	VALSARTAN	Proficient Rx LP	b58471fe-e2c6-4cc5-9d49-6a3111f6e002	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204821 application number: ANDA204821

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
349199	valsartan 80 MG Oral Tablet	PSN	03af7d09-314a-fe85-e063-6294a90afa25	4
349199	valsartan 80 MG Oral Tablet	SCD	03af7d09-314a-fe85-e063-6294a90afa25	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-653-52	51655065352	30 TABLET in 1 BOTTLE, PLASTIC (51655-653-52)	30 tablet	2023-08-15	No	No	Current