Home NDC 63629-6922-3 Valsartan
Product NDC 63629-6922
Requested package NDC 63629-6922-3
11-digit product format 636296922
Labeler code 63629
Product ID 63629-6922_9b59d301-8886-4408-a06a-f1f69289101f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021283
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-07-07
Marketing end 0000-00-00
Substance VALSARTAN
Active strength 80 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 1 of 3 · 81 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-6922-1 2020-10-16 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-2 2020-10-16 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-3 2020-10-16 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-4 2020-10-16 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-1 2020-01-31 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-2 2020-01-31 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-3 2020-01-31 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996 63629-6922-4 2020-01-31 These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan. Valsartan Tablets, USP Initial U.S. Approval: 1996
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 63629-6922-3 63629692203 60 TABLET in 1 BOTTLE (63629-6922-3) 60 tablet 2016-02-18 0000-00-00 No No Current