Valsartan

Product NDC
50090-2877
11-digit product format
500902877
Labeler code
50090
Product ID
50090-2877_66614354-fe36-4d14-ac0c-c0684f72d01d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202223
Marketing category
ANDA
Marketing start
2015-01-05
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

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 productproduct50090-2877IInactivated by FDA2026-10-05
excluded packagepackage50090-287750090-2877-0IInactivated by FDA2026-10-05
excluded packagepackage50090-287750090-2877-1IInactivated by FDA2026-10-05

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 packagepackage50090-2877-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2877-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2877-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2877-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2877-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2877-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2877-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2877-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2877-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2877-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2877-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2877-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2877-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2877-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2877-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2877-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2877-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2877-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2877-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2877-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2877-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2877-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2877-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2877-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2877-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2877-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2877-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2877-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2877-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2877-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202223-001VALSARTANVALSARTAN40MGTABLET / ORALAB2015-01-05
A202223-002VALSARTANVALSARTAN80MGTABLET / ORALAB2015-01-05
A202223-003VALSARTANVALSARTAN160MGTABLET / ORALAB2015-01-05
A202223-004VALSARTANVALSARTAN320MGTABLET / 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
A202223-001AB
A202223-002AB
A202223-003AB
A202223-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-09-14 22:38:342026-08A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0584e616aacf4f…
2026-08-18 06:07:402026-07A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-001VALSARTAN40MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-002VALSARTAN80MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-003VALSARTAN160MGTABLET / ORALAB2015-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-004VALSARTAN320MGTABLET / ORALAB2015-01-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202223-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202223-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202223-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202223-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A202223-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202223-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202223-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202223-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202223-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202223-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202223-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202223-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202223-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202223-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202223-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202223-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50090-2877-0Valsartan30 in 1 BOTTLETABLET, FILM COATED3021
50090-2877-1Valsartan90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2877-0EA - Each50090-287771b60c55-4414-47ce-8ed7-42c7846e456912019-04-11
50090-2877-1EA - Each50090-287760648a52-2705-4a5a-82df-5f328c45f55a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2877VALSARTAN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]21Legacy NDC, 2 package rows20210615_3ea2256a-0165-48d5-9d66-eabb83df3620.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValsartanVALSARTANAurobindo Pharma Limiteda81a72dd-e828-4208-af9b-bb9ac49385372024-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202223
application number: ANDA202223

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN3ea2256a-0165-48d5-9d66-eabb83df362021
349200valsartan 320 MG Oral TabletPSN3ea2256a-0165-48d5-9d66-eabb83df362021
349199valsartan 80 MG Oral TabletPSN3ea2256a-0165-48d5-9d66-eabb83df362021
349201valsartan 160 MG Oral TabletSCD3ea2256a-0165-48d5-9d66-eabb83df362021
349200valsartan 320 MG Oral TabletSCD3ea2256a-0165-48d5-9d66-eabb83df362021
349199valsartan 80 MG Oral TabletSCD3ea2256a-0165-48d5-9d66-eabb83df362021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2877-05009028770030 TABLET, FILM COATED in 1 BOTTLE (50090-2877-0) 2017-03-290000-00-00NoNoCurrent
50090-2877-15009028770190 TABLET, FILM COATED in 1 BOTTLE (50090-2877-1) 2017-02-210000-00-00NoNoCurrent