Home NDC 50090-4130 Valsartan
Product NDC 50090-4130
11-digit product format 500904130
Labeler code 50090
Product ID 50090-4130_53f0d994-2dbc-4f2a-ac08-1f86c87696f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA202696
Marketing category ANDA
Marketing start 2016-09-19
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A202696-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 A202696-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 A202696-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 A202696-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2016-09-16
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 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202696-001 VALSARTAN 40MG TABLET / ORAL AB 2016-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202696-002 VALSARTAN 80MG TABLET / ORAL AB 2016-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202696-003 VALSARTAN 160MG TABLET / ORAL AB 2016-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202696-004 VALSARTAN 320MG TABLET / ORAL AB 2016-09-16 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349200 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4130-0 Valsartan 30 in 1 BOTTLE TABLET, FILM COATED 30 8 50090-4130-1 Valsartan 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4130 VALSARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 8 Legacy NDC, 2 package rows 20210617_bb3c66a7-d397-4df5-822f-4a1f797f54fc.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 Macleods Pharmaceuticals Limited 251ccff4-bf86-453b-9d1c-e3c1ecfd3a46 2026-08-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202696 application number: ANDA202696 Valsartan VALSARTAN A-S Medication Solutions bb3c66a7-d397-4df5-822f-4a1f797f54fc 2026-07-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202696 application number: ANDA202696 ndc (product): 50090-4130 Valsartan VALSARTAN Northwind Health Company, LLC f305e9d7-341a-45f6-e053-2a95a90a2d69 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202696 application number: ANDA202696 VALSARTAN VALSARTAN Direct_Rx 946692f5-0fe2-89b7-e053-2995a90a4d91 2025-01-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202696 application number: ANDA202696 Valsartan VALSARTAN Proficient Rx LP fadb25bb-acd9-4aaf-971c-82259b739e5b 2022-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202696 application number: ANDA202696
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 50090-4130-0 50090413000 30 TABLET, FILM COATED in 1 BOTTLE (50090-4130-0) 2019-02-07 0000-00-00 No No Current 50090-4130-1 50090413001 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4130-1) 2016-09-19 0000-00-00 No No Current