Home NDC 72819-182 Valsartan
Product NDC 72819-182
11-digit product format 728190182
Labeler code 72819
Product ID 72819-182_0037a1a4-d769-2567-e063-6394a90a721c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET, COATED
Route ORAL
Labeler Archis Pharma LLC
Application ANDA205347
Marketing category ANDA
Marketing start 2022-09-01
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 2026-12-31
Current FDA listing Yes 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 A205347-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 A205347-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 A205347-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 A205347-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2018-04-09
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 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205347-001 VALSARTAN 40MG TABLET / ORAL AB 2018-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205347-002 VALSARTAN 80MG TABLET / ORAL AB 2018-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205347-003 VALSARTAN 160MG TABLET / ORAL AB 2018-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205347-004 VALSARTAN 320MG TABLET / ORAL AB 2018-04-09 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72819-182-09 Valsartan 90 in 1 BOTTLE, PLASTIC TABLET, COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72819-182 VALSARTAN TABLET, COATED [ARCHIS PHARMA LLC] 4 Current NDC, Legacy NDC, 1 package rows 20230712_00b235b2-a909-4628-b37c-bb02bc5bf7c6.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 SQUARE PHARMACEUTICALS LIMITED 5ee97546-2a7c-40fa-9e05-b7993a72dfbf 2023-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205347 application number: ANDA205347
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72819-182-09 72819018209 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72819-182-09) 2022-09-01 0000-00-00 No No Current