Valsartan

Product NDC: 33342-065
11-digit product format: 333420065
Labeler code: 33342
Product ID: 33342-065_1fff1472-c659-469c-8786-f3c9b6689524
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA202696
Marketing category: ANDA
Marketing start: 2016-09-19
Substance: VALSARTAN
Active strength: 320 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
A202696-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16
A202696-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16
A202696-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16
A202696-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202696-001	AB
A202696-002	AB
A202696-003	AB
A202696-004	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	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-001	VALSARTAN	40MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-002	VALSARTAN	80MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-003	VALSARTAN	160MG	TABLET / ORAL	AB	2016-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-004	VALSARTAN	320MG	TABLET / ORAL	AB	2016-09-16	`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	A202696-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202696-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202696-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202696-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202696-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202696-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202696-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202696-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202696-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202696-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202696-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202696-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202696-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Valsartan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	320 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
251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	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
33342-065-10	Valsartan	90 in 1 BOTTLE	TABLET, FILM COATED	90		8
33342-065-15	Valsartan	500 in 1 BOTTLE	TABLET, FILM COATED	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-065-10	EA - Each	33342-065	dd57a11d-5bee-4b11-a62d-0fe7059858e2	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-065	VALSARTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20221002_251ccff4-bf86-453b-9d1c-e3c1ecfd3a46.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Macleods Pharmaceuticals Limited	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 33342-065
Valsartan	VALSARTAN	A-S Medication Solutions	bb3c66a7-d397-4df5-822f-4a1f797f54fc	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696
Valsartan	VALSARTAN	Northwind Health Company, LLC	f305e9d7-341a-45f6-e053-2a95a90a2d69	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696
VALSARTAN	VALSARTAN	Direct_Rx	946692f5-0fe2-89b7-e053-2995a90a4d91	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696
Valsartan	VALSARTAN	Proficient Rx LP	fadb25bb-acd9-4aaf-971c-82259b739e5b	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202696 application number: ANDA202696

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	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349200	valsartan 320 MG Oral Tablet	PSN	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349200	valsartan 320 MG Oral Tablet	PSN	bb3c66a7-d397-4df5-822f-4a1f797f54fc	8
349483	valsartan 40 MG Oral Tablet	PSN	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349199	valsartan 80 MG Oral Tablet	PSN	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349201	valsartan 160 MG Oral Tablet	SCD	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349200	valsartan 320 MG Oral Tablet	SCD	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349200	valsartan 320 MG Oral Tablet	SCD	bb3c66a7-d397-4df5-822f-4a1f797f54fc	8
349483	valsartan 40 MG Oral Tablet	SCD	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349199	valsartan 80 MG Oral Tablet	SCD	251ccff4-bf86-453b-9d1c-e3c1ecfd3a46	8
349200	valsartan 320 MG Oral Tablet	PSN	fadb25bb-acd9-4aaf-971c-82259b739e5b	3
349200	valsartan 320 MG Oral Tablet	SCD	fadb25bb-acd9-4aaf-971c-82259b739e5b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-065-10	33342006510	90 TABLET, FILM COATED in 1 BOTTLE (33342-065-10)	2016-09-19	0000-00-00	No	No	Current
33342-065-15	33342006515	500 TABLET, FILM COATED in 1 BOTTLE (33342-065-15)	2016-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valsartan	Macleods Pharmaceuticals Limited	2026-08-05	Human Prescription Drug Label	9
Valsartan	A-S Medication Solutions	2026-07-13	Human Prescription Drug Label	10
Valsartan	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	3