Home NDC 61958-0801-5 Letairis
Product NDC 61958-0801
Requested package NDC 61958-0801-5
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022081-001 LETAIRIS AMBRISENTAN 5MG TABLET / ORAL AB RLD 2007-06-15 N022081-002 LETAIRIS AMBRISENTAN 10MG TABLET / ORAL AB RLD, RS 2007-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022081-001 8377933 2027-12-11 U-1754 2015-10-23 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 N022081-002 9549926 2031-10-14 U-1965 2017-02-16
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022081-001 LETAIRIS 5MG TABLET / ORAL AB RLD 2007-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022081-002 LETAIRIS 10MG TABLET / ORAL AB RLD, RS 2007-06-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 9474752 2027-12-11 U-1754 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022081-002 9549926 2031-10-14 U-1965 2017-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 8377933 2027-12-11 U-1754 2015-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 9474752 2027-12-11 U-1754 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-001 9549926 2031-10-14 U-1965 2017-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022081-002 8377933 2027-12-11 U-1754 2015-10-23 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Letairis
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMBRISENTAN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HW6NV07QEC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 722116 Internal RxNorm lookup 722120 Internal RxNorm lookup 722122 Internal RxNorm lookup 722124 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61958-0801-1 2025-08-26 These 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 61958-0801-1 2025-08-26 These 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 61958-0801-2 2025-08-26 These 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 61958-0801-2 2025-08-26 These 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 61958-0801-3 2025-08-26 These 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 61958-0801-3 2025-08-26 These 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 61958-0801-4 2025-08-26 These 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 61958-0801-4 2025-08-26 These 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 61958-0801-5 2025-08-26 These 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 61958-0801-5 2025-08-26 These 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 61958-0801-6 2025-08-26 These 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 61958-0801-6 2025-08-26 These 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 61958-0801-1 2025-07-29 These 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 61958-0801-1 2025-07-29 These 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 61958-0801-2 2025-07-29 These 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 61958-0801-2 2025-07-29 These 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 61958-0801-3 2025-07-29 These 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 61958-0801-3 2025-07-29 These 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 61958-0801-4 2025-07-29 These 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 61958-0801-4 2025-07-29 These 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 61958-0801-5 2025-07-29 These 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 61958-0801-5 2025-07-29 These 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 61958-0801-6 2025-07-29 These 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 61958-0801-6 2025-07-29 These 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 61958-0801-1 2025-02-14 These 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 61958-0801-1 2025-02-14 These 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 61958-0801-2 2025-02-14 These 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 61958-0801-2 2025-02-14 These 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 61958-0801-3 2025-02-14 These 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 61958-0801-3 2025-02-14 These 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 61958-0801-4 2025-02-14 These 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 61958-0801-4 2025-02-14 These 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 61958-0801-5 2025-02-14 These 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 61958-0801-5 2025-02-14 These 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 61958-0801-6 2025-02-14 These 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 61958-0801-6 2025-02-14 These 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 61958-0801-1 2025-01-30 These 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 61958-0801-1 2025-01-30 These 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 61958-0801-2 2025-01-30 These 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 61958-0801-2 2025-01-30 These 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 61958-0801-3 2025-01-30 These 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 61958-0801-3 2025-01-30 These 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 61958-0801-4 2025-01-30 These 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 61958-0801-4 2025-01-30 These 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 61958-0801-5 2025-01-30 These 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 61958-0801-5 2025-01-30 These 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 61958-0801-6 2025-01-30 These 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 61958-0801-6 2025-01-30 These 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 NDC Product Description Form Quantity Strength SPL version 61958-0801-1 Letairis 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 27 61958-0801-2 Letairis 3 in 1 CARTON TABLET, FILM COATED 3 27 61958-0801-2 Letairis 10 in 1 BLISTER PACK TABLET, FILM COATED 10 27 61958-0801-3 Letairis 10 in 1 BLISTER PACK TABLET, FILM COATED 10 27 61958-0801-3 Letairis 1 in 1 CARTON TABLET, FILM COATED 1 27 61958-0801-4 Letairis 10 in 1 BLISTER PACK TABLET, FILM COATED 10 27 61958-0801-4 Letairis 1 in 1 CARTON TABLET, FILM COATED 1 27 61958-0801-5 Letairis 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 27 61958-0801-6 Letairis 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMBRISENTAN ACTIVE INGREDIENT HW6NV07QEC LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 AMBRISENTAN ACTIVE MOIETY HW6NV07QEC LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 TALC INACTIVE INGREDIENT 7SEV7J4R1U LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-0801 LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC] 26 Current NDC, Legacy NDC, 9 package rows 20250427_725d4e73-6c83-477a-adc6-0ae4a133a844.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61958-0801-5 61958080105 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5) 2007-06-15 0000-00-00 No No Current