Home NDC 68180-278-09 Valsartan
Product NDC 68180-278
Requested package NDC 68180-278-09
11-digit product format 681800278
Labeler code 68180
Product ID 68180-278_f3d23e05-7ed7-4d56-9a9b-c721c3ad5f17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201677
Marketing category ANDA
Marketing start 2015-01-05
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 2022-12-31
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 43 .
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 A201677-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL 2015-01-05 A201677-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL 2015-01-05 A201677-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL 2015-01-05 A201677-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL 2015-01-05
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 · 172 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 2026-09-14 22:38:34 2026-08 A201677-001 VALSARTAN 40MG TABLET / ORAL 2015-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201677-002 VALSARTAN 80MG TABLET / ORAL 2015-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201677-003 VALSARTAN 160MG TABLET / ORAL 2015-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201677-004 VALSARTAN 320MG TABLET / ORAL 2015-01-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201677-001 VALSARTAN 40MG TABLET / ORAL 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201677-002 VALSARTAN 80MG TABLET / ORAL 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201677-003 VALSARTAN 160MG TABLET / ORAL 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201677-004 VALSARTAN 320MG TABLET / ORAL 2015-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201677-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201677-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201677-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201677-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-278-03 Valsartan 1000 in 1 BOTTLE TABLET 1000 19 68180-278-09 Valsartan 90 in 1 BOTTLE TABLET 90 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-278 VALSARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 19 Legacy NDC, 2 package rows 20240323_9eb9d98e-7057-4ca0-91ab-2030bc0120a6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-278-09 68180027809 90 TABLET in 1 BOTTLE (68180-278-09) 90 tablet 2015-01-05 0000-00-00 No No Current