VALSARTAN

Product NDC
51660-141
11-digit product format
516600141
Labeler code
51660
Product ID
51660-141_0ea6cbb4-10cd-fecf-e063-6394a90a513b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALSARTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA077492
Marketing category
ANDA
Marketing start
2014-07-07
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
2026-12-31
Current FDA listing
Yes

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
A077492-001VALSARTANVALSARTAN40MGTABLET / ORALAB2014-06-26
A077492-002VALSARTANVALSARTAN80MGTABLET / ORALAB2014-06-26
A077492-003VALSARTANVALSARTAN160MGTABLET / ORALAB2014-06-26
A077492-004VALSARTANVALSARTAN320MGTABLET / ORALAB2014-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077492-001AB
A077492-002AB
A077492-003AB
A077492-004AB

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 UTC2026-02A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077492-001VALSARTAN40MGTABLET / ORALAB2014-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-002VALSARTAN80MGTABLET / ORALAB2014-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-003VALSARTAN160MGTABLET / ORALAB2014-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-004VALSARTAN320MGTABLET / ORALAB2014-06-26d06236e962d9…

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 UTC2026-02A077492-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077492-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077492-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077492-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077492-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077492-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077492-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077492-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077492-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077492-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077492-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077492-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077492-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
VALSARTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80M03YXJ7IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349199Internal RxNorm lookup
349200Internal RxNorm lookup
349201Internal RxNorm lookup
349483Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65Available on FDA.report

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
51660-141-03VALSARTAN10 in 1 BOTTLETABLET, FILM COATED1010
51660-141-05VALSARTAN500 in 1 BOTTLETABLET, FILM COATED50010
51660-141-90VALSARTAN90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-141-90EA - Each51660-141e9ab513c-80dc-4c88-b515-fa95f9702e9f12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-141VALSARTAN TABLET, FILM COATED [OHM LABORATORIES INC.]10Current NDC, Legacy NDC, 3 package rows20240112_ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f65.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
VALSARTANVALSARTANOhm Laboratories Inc.ab5e0e5a-5bdf-4cfc-9d18-57ea4d642f652024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077492
application number: ANDA077492
ndc (product): 51660-141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349201valsartan 160 MG Oral TabletPSNab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349200valsartan 320 MG Oral TabletPSNab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349483valsartan 40 MG Oral TabletPSNab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349199valsartan 80 MG Oral TabletPSNab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349201valsartan 160 MG Oral TabletSCDab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349200valsartan 320 MG Oral TabletSCDab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349483valsartan 40 MG Oral TabletSCDab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510
349199valsartan 80 MG Oral TabletSCDab5e0e5a-5bdf-4cfc-9d18-57ea4d642f6510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51660-141-035166001410310 TABLET, FILM COATED in 1 BOTTLE (51660-141-03) 2014-07-070000-00-00NoNoCurrent
51660-141-0551660014105500 TABLET, FILM COATED in 1 BOTTLE (51660-141-05) 2014-07-070000-00-00NoNoCurrent
51660-141-905166001419090 TABLET, FILM COATED in 1 BOTTLE (51660-141-90) 2014-07-070000-00-00NoNoCurrent