Valsartan

Product NDC
72819-184
11-digit product format
728190184
Labeler code
72819
Product ID
72819-184_0037a1a4-d769-2567-e063-6394a90a721c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Archis Pharma LLC
Application
ANDA205347
Marketing category
ANDA
Marketing start
2022-09-01
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
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72819-184DDiscontinued by firm2026-08-10
excluded packagepackage72819-18472819-184-09DDiscontinued by firm2026-08-10

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
A205347-001VALSARTANVALSARTAN40MGTABLET / ORALAB2018-04-09
A205347-002VALSARTANVALSARTAN80MGTABLET / ORALAB2018-04-09
A205347-003VALSARTANVALSARTAN160MGTABLET / ORALAB2018-04-09
A205347-004VALSARTANVALSARTAN320MGTABLET / ORALAB2018-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205347-001AB
A205347-002AB
A205347-003AB
A205347-004AB

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 UTC2026-02A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205347-001VALSARTAN40MGTABLET / ORALAB2018-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-002VALSARTAN80MGTABLET / ORALAB2018-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-003VALSARTAN160MGTABLET / ORALAB2018-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-004VALSARTAN320MGTABLET / ORALAB2018-04-09d06236e962d9…

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 UTC2026-02A205347-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205347-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205347-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205347-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205347-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205347-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205347-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205347-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205347-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205347-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205347-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205347-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205347-004AB1d06236e962d9…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72819-184-09Valsartan90 in 1 BOTTLE, PLASTICTABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72819-184-09EA - Each72819-184aa0dabed-0a63-477e-abcf-7c3fd379cbcd12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-184VALSARTAN TABLET, COATED [ARCHIS PHARMA LLC]4Current NDC, Legacy NDC, 1 package rows20230712_00b235b2-a909-4628-b37c-bb02bc5bf7c6.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
ValsartanVALSARTANSQUARE PHARMACEUTICALS LIMITED5ee97546-2a7c-40fa-9e05-b7993a72dfbf2023-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205347
application number: ANDA205347

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSN00b235b2-a909-4628-b37c-bb02bc5bf7c64
349200valsartan 320 MG Oral TabletPSN00b235b2-a909-4628-b37c-bb02bc5bf7c64
349483valsartan 40 MG Oral TabletPSN00b235b2-a909-4628-b37c-bb02bc5bf7c64
349199valsartan 80 MG Oral TabletPSN00b235b2-a909-4628-b37c-bb02bc5bf7c64
349201valsartan 160 MG Oral TabletSCD00b235b2-a909-4628-b37c-bb02bc5bf7c64
349200valsartan 320 MG Oral TabletSCD00b235b2-a909-4628-b37c-bb02bc5bf7c64
349483valsartan 40 MG Oral TabletSCD00b235b2-a909-4628-b37c-bb02bc5bf7c64
349199valsartan 80 MG Oral TabletSCD00b235b2-a909-4628-b37c-bb02bc5bf7c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72819-184-097281901840990 TABLET, COATED in 1 BOTTLE, PLASTIC (72819-184-09) 2022-09-010000-00-00NoNoCurrent