Valsartan

Product NDC: 29300-235
11-digit product format: 293000235
Labeler code: 29300
Product ID: 29300-235_4d1e743f-8954-4634-b95b-adb7ae41a549
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA209261
Marketing category: ANDA
Marketing start: 2018-05-04
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 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	Approval date
A209261-001	VALSARTAN	VALSARTAN	40MG	TABLET / ORAL	2018-05-04
A209261-002	VALSARTAN	VALSARTAN	80MG	TABLET / ORAL	2018-05-04
A209261-003	VALSARTAN	VALSARTAN	160MG	TABLET / ORAL	2018-05-04
A209261-004	VALSARTAN	VALSARTAN	320MG	TABLET / ORAL	2018-05-04

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209261-001	VALSARTAN	40MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-002	VALSARTAN	80MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-003	VALSARTAN	160MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209261-004	VALSARTAN	320MG	TABLET / ORAL	2018-05-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209261-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209261-004	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A209261-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209261-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209261-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209261-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209261-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209261-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209261-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209261-004	AB	1	`ea99ee380514…`

Additional Listing Data#

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

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
93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	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
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	SPL version
29300-235-10	Valsartan	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	8
29300-235-13	Valsartan	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	8
29300-235-19	Valsartan	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-235-19	EA - Each	29300-235	ee18b684-787e-462b-bee4-a6f918849361	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-235	VALSARTAN TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	8	Current NDC, Legacy NDC, 3 package rows	20210916_93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valsartan	VALSARTAN	Unichem Pharmaceuticals (USA), Inc.	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	2021-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209261 application number: ANDA209261 ndc (product): 29300-235

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	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349200	valsartan 320 MG Oral Tablet	PSN	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349483	valsartan 40 MG Oral Tablet	PSN	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349199	valsartan 80 MG Oral Tablet	PSN	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349201	valsartan 160 MG Oral Tablet	SCD	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349200	valsartan 320 MG Oral Tablet	SCD	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349483	valsartan 40 MG Oral Tablet	SCD	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8
349199	valsartan 80 MG Oral Tablet	SCD	93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-235-10	29300023510	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-235-10)	2018-05-15	0000-00-00	No	No	Current
29300-235-13	29300023513	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-235-13)	2018-05-15	0000-00-00	No	No	Current
29300-235-19	29300023519	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-235-19)	2018-05-15	0000-00-00	No	No	Current