Home NDC 10135-769 Valsartan
Product NDC 10135-769
11-digit product format 101350769
Labeler code 10135
Product ID 10135-769_efcc5f0c-4eb2-8d75-e053-2995a90a932c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA205347
Marketing category ANDA
Marketing start 2022-12-01
Marketing end 0000-00-00
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 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10135-769-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10135-769-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10135-769-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10135-769-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10135-769-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10135-769-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10135-769-90 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10135-769-90 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10135-769-90 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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.
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 10135-769-90 Valsartan 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-769 VALSARTAN TABLET [MARLEX PHARMACEUTICALS, INC.] 2 Legacy NDC, 1 package rows 20230708_efcc5d9e-e8d8-2da3-e053-2a95a90ac3d9.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valsartan VALSARTAN SQUARE PHARMACEUTICALS LIMITED 5ee97546-2a7c-40fa-9e05-b7993a72dfbf 2023-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205347 application number: ANDA205347
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 10135-769-90 10135076990 90 TABLET in 1 BOTTLE (10135-769-90) 90 tablet 2022-12-01 0000-00-00 No No Current