Valsartan

Product NDC
71335-1436
Requested package NDC
71335-1436-3
11-digit product format
713351436
Labeler code
71335
Product ID
71335-1436_05516ebb-f430-4431-ad4f-59acdb18e72e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091367
Marketing category
ANDA
Marketing start
2016-05-20
Marketing end
0000-00-00
Substance
VALSARTAN
Active strength
160 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-143671335-1436-3IInactivated by FDA2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091367-001VALSARTANVALSARTAN40MGTABLET / ORALAB2015-01-05
A091367-002VALSARTANVALSARTAN80MGTABLET / ORALAB2015-01-05
A091367-003VALSARTANVALSARTAN160MGTABLET / ORALAB2015-01-05
A091367-004VALSARTANVALSARTAN320MGTABLET / ORALAB2015-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091367-001AB
A091367-002AB
A091367-003AB
A091367-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091367-001VALSARTAN40MGTABLET / ORALAB2015-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-002VALSARTAN80MGTABLET / ORALAB2015-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-003VALSARTAN160MGTABLET / ORALAB2015-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-004VALSARTAN320MGTABLET / ORALAB2015-01-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091367-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091367-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091367-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091367-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091367-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091367-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091367-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091367-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091367-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091367-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091367-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091367-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091367-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
71335-1436-1These 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
71335-1436-2These 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
71335-1436-3These 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
71335-1436-4These 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
71335-1436-5These 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
71335-1436-6These 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
71335-1436-7These 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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANAlembic Pharmaceuticals Limited6e2cd953-88bf-4094-8ba8-2c9ba020f4d72023-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091367
application number: ANDA091367
ValsartanVALSARTANAlembic Pharmaceuticals Inc.8478a05f-38fd-412d-af49-69a73a787c8f2021-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091367
application number: ANDA091367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1436-371335143603120 TABLET in 1 BOTTLE (71335-1436-3) 120 tablet2021-12-280000-00-00NoNoCurrent