Home NDC 55289-817-30 Diovan
Product NDC 55289-817
Requested package NDC 55289-817-30
11-digit product format 552890817
Labeler code 55289
Product ID 55289-817_dac02142-80d7-6923-e053-2995a90ad38a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021283
Marketing category NDA
Marketing start 2001-07-01
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 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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 55289-817-30 55289081730 30 TABLET in 1 BOTTLE, PLASTIC (55289-817-30) 30 tablet 2011-04-01 0000-00-00 No No Current