FDA.reportPublic FDA data

Letairis

Product NDC
61958-0801
11-digit product format
619580801
Labeler code
61958
Product ID
61958-0801_273ba426-0edb-47a2-b5d3-883cd1b9369a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMBRISENTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA022081
Marketing category
NDA
Marketing start
2007-06-15
Substance
AMBRISENTAN
Active strength
5 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBRISENTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHW6NV07QEC
Rxcui722116, 722120, 722122, 722124

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0801-12025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-22025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-32025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-42025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-52025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-62025-08-26C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-12025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-22025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-32025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-42025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-52025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-62025-07-29C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-12025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-22025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-32025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-42025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-52025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-62025-02-14C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-12025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-22025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-32025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-42025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-52025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-62025-01-30C16284748780-12cef2736-6d47-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0801-1Letairis30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3027
61958-0801-2Letairis3 in 1 CARTONTABLET, FILM COATED327
61958-0801-2Letairis10 in 1 BLISTER PACKTABLET, FILM COATED1027
61958-0801-3Letairis10 in 1 BLISTER PACKTABLET, FILM COATED1027
61958-0801-3Letairis1 in 1 CARTONTABLET, FILM COATED127
61958-0801-4Letairis10 in 1 BLISTER PACKTABLET, FILM COATED1027
61958-0801-4Letairis1 in 1 CARTONTABLET, FILM COATED127
61958-0801-5Letairis10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1027
61958-0801-6Letairis10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0801-1EA - Each61958-08013ea7295c-ef90-4822-8401-2e857e5b728812013-08-02
61958-0801-2EA - Each61958-08018e81ffb7-bfe7-4ab6-ae49-efa72649ddfc12012-07-24
61958-0801-3EA - Each61958-0801489ffd10-5506-4a24-91f9-f4f6b883c34612013-02-13
61958-0801-5EA - Each61958-08015e30fce9-e6c9-4b8d-a9d3-d5af68e9745d12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMBRISENTANACTIVE INGREDIENTHW6NV07QECLETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
AMBRISENTANACTIVE MOIETYHW6NV07QECLETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
TALCINACTIVE INGREDIENT7SEV7J4R1ULETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0801LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]26Current NDC, Legacy NDC, 9 package rows20250427_725d4e73-6c83-477a-adc6-0ae4a133a844.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSN725d4e73-6c83-477a-adc6-0ae4a133a84427
722122ambrisentan 5 MG Oral TabletPSN725d4e73-6c83-477a-adc6-0ae4a133a84427
722120Letairis 10 MG Oral TabletPSN725d4e73-6c83-477a-adc6-0ae4a133a84427
722124Letairis 5 MG Oral TabletPSN725d4e73-6c83-477a-adc6-0ae4a133a84427
722120ambrisentan 10 MG Oral Tablet [Letairis]SBD725d4e73-6c83-477a-adc6-0ae4a133a84427
722124ambrisentan 5 MG Oral Tablet [Letairis]SBD725d4e73-6c83-477a-adc6-0ae4a133a84427
722116ambrisentan 10 MG Oral TabletSCD725d4e73-6c83-477a-adc6-0ae4a133a84427
722122ambrisentan 5 MG Oral TabletSCD725d4e73-6c83-477a-adc6-0ae4a133a84427
722120Letairis 10 MG Oral TabletSY725d4e73-6c83-477a-adc6-0ae4a133a84427
722124Letairis 5 MG Oral TabletSY725d4e73-6c83-477a-adc6-0ae4a133a84427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-0801-16195808010130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1) 2007-06-150000-00-00NoNoCurrent
61958-0801-2619580801023 BLISTER PACK in 1 CARTON (61958-0801-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2007-06-150000-00-00NoNoCurrent
61958-0801-3619580801031 BLISTER PACK in 1 CARTON (61958-0801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2007-06-150000-00-00NoNoCurrent
61958-0801-4619580801041 BLISTER PACK in 1 CARTON (61958-0801-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2007-06-150000-00-00NoNoCurrent
61958-0801-56195808010510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5) 2007-06-150000-00-00NoNoCurrent
61958-0801-66195808010610 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-6) 2007-06-150000-00-00NoNoCurrent