Home NDC 59746-360 valsartan
Product NDC 59746-360
11-digit product format 597460360
Labeler code 59746
Product ID 59746-360_9c828bee-09d3-4021-99e7-e5fd3e83741c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET
Route ORAL
Labeler Jubilant Cadista Pharmacuticals Inc.
Application ANDA203536
Marketing category ANDA
Marketing start 2015-01-05
Substance VALSARTAN
Active strength 40 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 A203536-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 A203536-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 A203536-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 A203536-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2015-01-05
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 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203536-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203536-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203536-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203536-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 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 40 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-360-03 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-03 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-05 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-05 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-30 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-30 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-90 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-90 2023-02-24 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-03 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-03 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-05 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-05 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-30 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-30 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-90 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996 59746-360-90 2023-01-30 These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59746-360-03 valsartan 10 in 1 CARTON TABLET 10 9 59746-360-03 valsartan 10 in 1 BLISTER PACK TABLET 10 9 59746-360-05 valsartan 500 in 1 BOTTLE TABLET 500 9 59746-360-30 valsartan 30 in 1 BOTTLE TABLET 30 9 59746-360-90 valsartan 90 in 1 BOTTLE TABLET 90 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-360 VALSARTAN TABLET [JUBILANT CADISTA PHARMACUTICALS INC.] 9 Current NDC, Legacy NDC, 5 package rows 20250305_9402b022-5809-4251-dfef-54f6ef5723fe.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join valsartan VALSARTAN Northwind Health Company, LLC db4801e5-6e0f-2cb3-e053-2995a90a709a 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203536 application number: ANDA203536 valsartan VALSARTAN PD-Rx Pharmaceuticals, Inc. 5afd7c3d-c66b-479c-bfd0-6c04658b157d 2025-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203536 application number: ANDA203536 valsartan VALSARTAN A-S Medication Solutions 80987771-ccb4-4a9f-a395-0af4c2621e0a 2023-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203536 application number: ANDA203536 valsartan VALSARTAN A-S Medication Solutions e352db8b-0485-492a-8734-0a415566d764 2023-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203536 application number: ANDA203536 valsartan VALSARTAN A-S Medication Solutions 9f5a400f-9cfc-4d25-a677-73cbb14375e2 2023-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203536 application number: ANDA203536
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 59746-360-03 59746036003 10 BLISTER PACK in 1 CARTON (59746-360-03) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2015-01-05 0000-00-00 No No Current 59746-360-05 59746036005 500 TABLET in 1 BOTTLE (59746-360-05) 500 tablet 2015-01-05 0000-00-00 No No Current 59746-360-30 59746036030 30 TABLET in 1 BOTTLE (59746-360-30) 30 tablet 2015-01-05 0000-00-00 No No Current 59746-360-90 59746036090 90 TABLET in 1 BOTTLE (59746-360-90) 90 tablet 2015-01-05 0000-00-00 No No Current