valsartan

Product NDC: 59746-393
11-digit product format: 597460393
Labeler code: 59746
Product ID: 59746-393_1e2b0e94-49d1-44bd-9564-20991a251f5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA203536
Marketing category: ANDA
Marketing start: 2026-08-24
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203536-001	VALSARTAN	40MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-002	VALSARTAN	80MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-003	VALSARTAN	160MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-004	VALSARTAN	320MG	TABLET / ORAL	AB	2015-01-05	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203536-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203536-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203536-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203536-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203536-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203536-004	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
9402b022-5809-4251-dfef-54f6ef5723fe	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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Crospovidone	INACTIVE INGREDIENT	68401960MK	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	VALSARTAN TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	1

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	Jubilant Cadista Pharmaceuticals Inc.	9402b022-5809-4251-dfef-54f6ef5723fe	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203536 application number: ANDA203536 ndc (product): 59746-393
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
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	9402b022-5809-4251-dfef-54f6ef5723fe	9
349200	valsartan 320 MG Oral Tablet	PSN	9402b022-5809-4251-dfef-54f6ef5723fe	9
349483	valsartan 40 MG Oral Tablet	PSN	9402b022-5809-4251-dfef-54f6ef5723fe	9
349199	valsartan 80 MG Oral Tablet	PSN	9402b022-5809-4251-dfef-54f6ef5723fe	9
349201	valsartan 160 MG Oral Tablet	SCD	9402b022-5809-4251-dfef-54f6ef5723fe	9
349200	valsartan 320 MG Oral Tablet	SCD	9402b022-5809-4251-dfef-54f6ef5723fe	9
349483	valsartan 40 MG Oral Tablet	SCD	9402b022-5809-4251-dfef-54f6ef5723fe	9
349199	valsartan 80 MG Oral Tablet	SCD	9402b022-5809-4251-dfef-54f6ef5723fe	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59746-393-30	59746039330	30 TABLET in 1 BOTTLE (59746-393-30)	30 tablet	2026-08-24	No	No	Current
59746-393-32	59746039332	3 BLISTER PACK in 1 CARTON (59746-393-32) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2026-08-24	No	No	Current
59746-393-67	59746039367	400 TABLET in 1 BOTTLE (59746-393-67)	400 tablet	2026-08-24	No	No	Current
59746-393-90	59746039390	90 TABLET in 1 BOTTLE (59746-393-90)	90 tablet	2026-08-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
valsartan	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	2026-08-26	Human Prescription Drug Label	12