Home NDC 42291-857 Valsartan
Product NDC 42291-857
11-digit product format 422910857
Labeler code 42291
Product ID 42291-857_488420ae-b4b5-d0ab-e063-6394a90a89bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA204011
Marketing category ANDA
Marketing start 2020-06-23
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 2027-12-31
Current FDA listing Yes 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 A204011-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 A204011-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 A204011-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 A204011-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2016-01-11
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 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204011-001 VALSARTAN 40MG TABLET / ORAL AB 2016-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204011-002 VALSARTAN 80MG TABLET / ORAL AB 2016-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204011-003 VALSARTAN 160MG TABLET / ORAL AB 2016-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204011-004 VALSARTAN 320MG TABLET / ORAL AB 2016-01-11 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2027-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-857-90 Valsartan 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-857 VALSARTAN TABLET [AVKARE] 3 Current NDC, Legacy NDC, 1 package rows 20240111_a8c61488-4219-dfcb-e053-2a95a90a98a4.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 · 3 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 42291-857-90 42291085790 90 TABLET in 1 BOTTLE (42291-857-90) 90 tablet 2020-06-23 0000-00-00 No No Current