Home NDC 43353-059 Valsartan
Product NDC 43353-059
11-digit product format 433530059
Labeler code 43353
Product ID 43353-059_0f5111d6-a380-40d6-ae3f-6fbcd975c962
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021283
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-07-07
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 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.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021283-001 DIOVAN 80MG TABLET / ORAL AB RLD 2001-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021283-002 DIOVAN 160MG TABLET / ORAL AB RLD 2001-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021283-003 DIOVAN 320MG TABLET / ORAL AB RLD, RS 2001-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021283-004 DIOVAN 40MG TABLET / ORAL AB RLD 2002-08-14 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 3 of 3 · 81 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021283-004 NPP 2024-04-19 cb3db0bc1861…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-059 VALSARTAN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20160708_f8b24f6f-17e5-4899-8c70-30a7548e00d8.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 2026-08-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021283 application number: NDA021283
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-059-17 43353005917 6030 TABLET in 1 BOTTLE (43353-059-17) 6030 tablet 2015-05-31 0000-00-00 No No Current 43353-059-30 43353005930 30 TABLET in 1 BOTTLE (43353-059-30) 30 tablet 2015-10-16 0000-00-00 No No Current