Home NDC 53746-840 Valsartan
Product NDC 53746-840
11-digit product format 537460840
Labeler code 53746
Product ID 53746-840_254b9473-bbcb-4780-a182-ba287b886a47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA204011
Marketing category ANDA
Marketing start 2022-10-10
Substance VALSARTAN
Active strength 320 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 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 320 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 53746-840-05 Valsartan 500 in 1 BOTTLE TABLET 500 21 53746-840-10 Valsartan 1000 in 1 BOTTLE TABLET 1000 21 53746-840-90 Valsartan 90 in 1 BOTTLE TABLET 90 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-840 VALSARTAN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 21 Current NDC, 3 package rows 20240420_f13587f8-76cb-49ad-9291-5907249d6b8e.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 Sample Exclude flag Status 53746-840-05 53746084005 500 TABLET in 1 BOTTLE (53746-840-05) 500 tablet 2022-10-10 No No Current 53746-840-10 53746084010 1000 TABLET in 1 BOTTLE (53746-840-10) 1000 tablet 2022-10-10 No No Current 53746-840-90 53746084090 90 TABLET in 1 BOTTLE (53746-840-90) 90 tablet 2022-10-10 No No Current