Valsartan

Product NDC
50090-4837
11-digit product format
500904837
Labeler code
50090
Product ID
50090-4837_ab9e18ba-a440-469d-9590-e0d869e5e8b1
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
160 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4837IInactivated by FDA2026-08-17
excluded packagepackage50090-483750090-4837-0IInactivated by FDA2026-08-17
excluded packagepackage50090-483750090-4837-1IInactivated by FDA2026-08-17

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4837-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4837-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4837-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4837-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4837-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4837-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4837-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4837-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4837-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4837-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4837-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4837-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4837-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4837-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4837-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4837-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4837-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4837-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4837-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4837-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4837-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4837-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4837-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4837-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4837-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4837-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4837-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4837-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4837-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4837-11332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202696-001VALSARTANVALSARTAN40MGTABLET / ORALAB2016-09-16
A202696-002VALSARTANVALSARTAN80MGTABLET / ORALAB2016-09-16
A202696-003VALSARTANVALSARTAN160MGTABLET / ORALAB2016-09-16
A202696-004VALSARTANVALSARTAN320MGTABLET / ORALAB2016-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202696-001AB
A202696-002AB
A202696-003AB
A202696-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-001VALSARTAN40MGTABLET / ORALAB2016-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-002VALSARTAN80MGTABLET / ORALAB2016-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-003VALSARTAN160MGTABLET / ORALAB2016-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-004VALSARTAN320MGTABLET / ORALAB2016-09-16d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202696-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202696-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202696-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202696-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202696-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202696-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202696-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202696-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202696-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202696-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202696-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202696-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202696-004AB1d8e5a09893c0…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4837-0Valsartan30 in 1 BOTTLETABLET, FILM COATED303
50090-4837-1Valsartan90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4837VALSARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210615_6ec2aea6-2578-496e-ab49-02ddd89a1644.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANMacleods Pharmaceuticals Limited251ccff4-bf86-453b-9d1c-e3c1ecfd3a462026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202696
application number: ANDA202696
ValsartanVALSARTANA-S Medication Solutionsbb3c66a7-d397-4df5-822f-4a1f797f54fc2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202696
application number: ANDA202696
ValsartanVALSARTANNorthwind Health Company, LLCf305e9d7-341a-45f6-e053-2a95a90a2d692026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202696
application number: ANDA202696
VALSARTANVALSARTANDirect_Rx946692f5-0fe2-89b7-e053-2995a90a4d912025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202696
application number: ANDA202696
ValsartanVALSARTANProficient Rx LPfadb25bb-acd9-4aaf-971c-82259b739e5b2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202696
application number: ANDA202696

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN6ec2aea6-2578-496e-ab49-02ddd89a16443
349201valsartan 160 MG Oral TabletSCD6ec2aea6-2578-496e-ab49-02ddd89a16443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4837-05009048370030 TABLET, FILM COATED in 1 BOTTLE (50090-4837-0) 2020-01-160000-00-00NoNoCurrent
50090-4837-15009048370190 TABLET, FILM COATED in 1 BOTTLE (50090-4837-1) 2020-01-200000-00-00NoNoCurrent