Home NDC 76483-023 Valsartan
Product NDC 76483-023
11-digit product format 764830023
Labeler code 76483
Product ID 76483-023_9f718442-a70e-4f30-8a1e-456392400ec0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler SQUARE PHARMACEUTICALS LIMITED
Application ANDA205347
Marketing category ANDA
Marketing start 2022-07-15
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.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349199 Internal RxNorm lookup 349200 Internal RxNorm lookup 349201 Internal RxNorm lookup 349483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76483-023 VALSARTAN TABLET [SQUARE PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 5 package rows 20230706_5ee97546-2a7c-40fa-9e05-b7993a72dfbf.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 76483-023-00 76483002300 30 TABLET in 1 BOTTLE (76483-023-00) 30 tablet 2022-07-15 0000-00-00 No No Current 76483-023-03 76483002303 90 TABLET in 1 BOTTLE (76483-023-03) 90 tablet 2022-07-15 0000-00-00 No No Current 76483-023-04 76483002304 100 TABLET in 1 BOTTLE (76483-023-04) 100 tablet 2022-07-15 0000-00-00 No No Current 76483-023-05 76483002305 500 TABLET in 1 BOTTLE (76483-023-05) 500 tablet 2022-07-15 0000-00-00 No No Current 76483-023-06 76483002306 1000 TABLET in 1 BOTTLE (76483-023-06) 1000 tablet 2022-07-15 0000-00-00 No No Current