Diovan

Product NDC: 0078-0359
11-digit product format: 000780359
Labeler code: 0078
Product ID: 0078-0359_bb542e5b-0b85-45db-8542-e203b9cd8618
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021283
Marketing category: NDA
Marketing start: 2001-07-01
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	RLD / RS	Approval date
N021283-001	DIOVAN	VALSARTAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-002	DIOVAN	VALSARTAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18
N021283-003	DIOVAN	VALSARTAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18
N021283-004	DIOVAN	VALSARTAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021283-001	AB
N021283-002	AB
N021283-003	AB
N021283-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	DIOVAN	80MG	TABLET / ORAL	AB	RLD	2001-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	DIOVAN	160MG	TABLET / ORAL	AB	RLD	2001-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-003	DIOVAN	320MG	TABLET / ORAL	AB	RLD, RS	2001-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	DIOVAN	40MG	TABLET / ORAL	AB	RLD	2002-08-14	`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	N021283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021283-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021283-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021283-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021283-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021283-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	AB	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-001	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-002	NPP	2024-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021283-004	NPP	2024-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-001	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-002	NPP	2024-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021283-004	NPP	2024-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-001	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-002	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021283-004	NPP	2024-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-001	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-002	NPP	2024-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021283-004	NPP	2024-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021283-001	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-002	NPP	2024-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021283-004	NPP	2024-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-001	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-002	NPP	2024-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021283-004	NPP	2024-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-001	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-002	NPP	2024-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021283-004	NPP	2024-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-001	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-002	NPP	2024-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021283-004	NPP	2024-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021283-001	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-002	NPP	2024-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021283-004	NPP	2024-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-001	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-002	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021283-004	NPP	2024-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021283-001	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-002	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021283-004	NPP	2024-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021283-001	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-002	NPP	2024-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021283-004	NPP	2024-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021283-001	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-002	NPP	2024-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021283-004	NPP	2024-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021283-001	NPP	2024-04-19	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diovan
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 · 8 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
351761	Internal RxNorm lookup
351762	Internal RxNorm lookup
352001	Internal RxNorm lookup
352274	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
5ddba454-f3e6-43c2-a7a6-58365d297213	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
0078-0359-34	Diovan	90 in 1 BOTTLE	TABLET	90		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0359-06	EA - Each	0078-0359	73ca538b-527a-4cbb-9a67-40897d4cb457	1	2012-07-24
0078-0359-17	EA - Each	0078-0359	c115c72b-354c-4a7a-8334-d1fedcb4e913	1	2012-07-24
0078-0359-34	EA - Each	0078-0359	244bcc3e-3603-43cc-b6d0-f7ccb598ea69	1	2012-07-24
0078-0359-61	EA - Each	0078-0359	03f1b9f3-71b5-440d-ba1f-8db5e4f91fe3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	15
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [PD-RX PHARMACEUTICALS, INC.]	7
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN (VALSARTAN) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0359	DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	29	Current NDC, Legacy NDC, 1 package rows	20250110_5ddba454-f3e6-43c2-a7a6-58365d297213.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
Diovan	VALSARTAN	Novartis Pharmaceuticals Corporation	5ddba454-f3e6-43c2-a7a6-58365d297213	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021283 application number: NDA021283 ndc (product): 0078-0359

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
351762	Diovan 160 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352001	Diovan 320 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352274	Diovan 40 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351761	Diovan 80 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349201	valsartan 160 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349200	valsartan 320 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349483	valsartan 40 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349199	valsartan 80 MG Oral Tablet	PSN	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351762	valsartan 160 MG Oral Tablet [Diovan]	SBD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352001	valsartan 320 MG Oral Tablet [Diovan]	SBD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352274	valsartan 40 MG Oral Tablet [Diovan]	SBD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351761	valsartan 80 MG Oral Tablet [Diovan]	SBD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349201	valsartan 160 MG Oral Tablet	SCD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349200	valsartan 320 MG Oral Tablet	SCD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349483	valsartan 40 MG Oral Tablet	SCD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
349199	valsartan 80 MG Oral Tablet	SCD	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351762	Diovan 160 MG Oral Tablet	SY	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352001	Diovan 320 MG Oral Tablet	SY	5ddba454-f3e6-43c2-a7a6-58365d297213	31
352274	Diovan 40 MG Oral Tablet	SY	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351761	Diovan 80 MG Oral Tablet	SY	5ddba454-f3e6-43c2-a7a6-58365d297213	31
351762	Diovan 160 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352001	Diovan 320 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352274	Diovan 40 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351761	Diovan 80 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349201	valsartan 160 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349200	valsartan 320 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349483	valsartan 40 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349199	valsartan 80 MG Oral Tablet	PSN	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351762	valsartan 160 MG Oral Tablet [Diovan]	SBD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352001	valsartan 320 MG Oral Tablet [Diovan]	SBD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352274	valsartan 40 MG Oral Tablet [Diovan]	SBD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351761	valsartan 80 MG Oral Tablet [Diovan]	SBD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349201	valsartan 160 MG Oral Tablet	SCD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349200	valsartan 320 MG Oral Tablet	SCD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349483	valsartan 40 MG Oral Tablet	SCD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
349199	valsartan 80 MG Oral Tablet	SCD	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351762	Diovan 160 MG Oral Tablet	SY	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352001	Diovan 320 MG Oral Tablet	SY	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
352274	Diovan 40 MG Oral Tablet	SY	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351761	Diovan 80 MG Oral Tablet	SY	e80642ad-bb06-4546-ae33-5bc70cf05cee	3
351762	Diovan 160 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	Diovan 80 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
349201	valsartan 160 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
349199	valsartan 80 MG Oral Tablet	PSN	c6488119-6547-4abd-bc15-a809b6107d4f	2
351762	valsartan 160 MG Oral Tablet [Diovan]	SBD	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	valsartan 80 MG Oral Tablet [Diovan]	SBD	c6488119-6547-4abd-bc15-a809b6107d4f	2
349201	valsartan 160 MG Oral Tablet	SCD	c6488119-6547-4abd-bc15-a809b6107d4f	2
349199	valsartan 80 MG Oral Tablet	SCD	c6488119-6547-4abd-bc15-a809b6107d4f	2
351762	Diovan 160 MG Oral Tablet	SY	c6488119-6547-4abd-bc15-a809b6107d4f	2
351761	Diovan 80 MG Oral Tablet	SY	c6488119-6547-4abd-bc15-a809b6107d4f	2
351762	Diovan 160 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
352001	Diovan 320 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
351761	Diovan 80 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349201	valsartan 160 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349200	valsartan 320 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349199	valsartan 80 MG Oral Tablet	PSN	d73a7aa3-5b5f-4532-9936-752366a2430d	1
351762	valsartan 160 MG Oral Tablet [Diovan]	SBD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
352001	valsartan 320 MG Oral Tablet [Diovan]	SBD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
351761	valsartan 80 MG Oral Tablet [Diovan]	SBD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349201	valsartan 160 MG Oral Tablet	SCD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349200	valsartan 320 MG Oral Tablet	SCD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
349199	valsartan 80 MG Oral Tablet	SCD	d73a7aa3-5b5f-4532-9936-752366a2430d	1
351762	Diovan 160 MG Oral Tablet	SY	d73a7aa3-5b5f-4532-9936-752366a2430d	1
352001	Diovan 320 MG Oral Tablet	SY	d73a7aa3-5b5f-4532-9936-752366a2430d	1
351761	Diovan 80 MG Oral Tablet	SY	d73a7aa3-5b5f-4532-9936-752366a2430d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0359-34	00078035934	90 TABLET in 1 BOTTLE (0078-0359-34)	90 tablet	2001-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diovan	Novartis Pharmaceuticals Corporation \| Novartis d.o.o. \| Packaging Coordinators, LLC	2025-12-22	HUMAN PRESCRIPTION DRUG LABEL	31
Diovan	PD-Rx Pharmaceuticals, Inc.	2022-03-21	HUMAN PRESCRIPTION DRUG LABEL	24
Diovan	Aphena Pharma Solutions - Tennessee, LLC	2014-05-08	HUMAN PRESCRIPTION DRUG LABEL	2
Diovan	Physicians Total Care, Inc.	2012-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
Diovan	Rebel Distributors Corp	2011-07-22	HUMAN PRESCRIPTION DRUG LABEL	1