Home NDC 51655-751 Valsartan
Product NDC 51655-751
11-digit product format 516550751
Labeler code 51655
Product ID 51655-751_3058d174-bff7-49db-8ca1-fa2d61898b9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northwind Pharmaceuticals
Application ANDA077492
Marketing category ANDA
Marketing start 2015-01-07
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 2019-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51655-751-52 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51655-751-52 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51655-751-52 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51655-751-52 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51655-751-52 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51655-751-52 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51655-751-52 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51655-751-52 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51655-751-52 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 51655-751-52 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 51655-751-52 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 51655-751-52 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 51655-751-52 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 51655-751-52 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 51655-751-52 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 51655-751-52 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 51655-751-52 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 51655-751-52 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 51655-751-52 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 51655-751-52 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 51655-751-52 9bebd1f3094a…5416666fcb17…
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 A077492-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 A077492-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 A077492-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 A077492-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2014-06-26
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 · 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 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077492-001 VALSARTAN 40MG TABLET / ORAL AB 2014-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077492-002 VALSARTAN 80MG TABLET / ORAL AB 2014-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077492-003 VALSARTAN 160MG TABLET / ORAL AB 2014-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077492-004 VALSARTAN 320MG TABLET / ORAL AB 2014-06-26 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-751 VALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 1 Legacy NDC 20150428_8841770a-ab65-4907-b036-e2eaca982411.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 VALSARTAN VALSARTAN Ohm Laboratories Inc. ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65 2024-01-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077492 application number: ANDA077492