Home NDC 49502-806 YUPELRI
Product NDC 49502-806
11-digit product format 495020806
Labeler code 49502
Product ID 49502-806_b7b789a7-deb0-41d7-9c7d-e6cf68d1b893
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name revefenacin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Viatris Specialty LLC
Application NDA210598
Marketing category NDA
Marketing start 2018-12-03
Substance REVEFENACIN
Active strength 175 ug/3mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210598-001 YUPELRI REVEFENACIN 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 N210598-001 11484531 2039-10-23 U-2440 2022-11-02
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 2 · 41 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 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 18 · 690 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 N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11484531 2039-10-23 U-2440 2022-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10106503 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10343995 2025-03-10 U-2440 2019-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11247969 2025-03-10 Drug product 2022-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7491736 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7521041 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7550595 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7585879 2025-03-10 U-2440 Drug substance, Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7910608 2025-03-10 Drug substance, Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8034946 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8053448 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8273894 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11484531 2039-10-23 U-2440 2022-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210598-001 10106503 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 10343995 2025-03-10 U-2440 2019-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 11247969 2025-03-10 Drug product 2022-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7491736 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7521041 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7550595 2025-03-10 Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7585879 2025-03-10 U-2440 Drug substance, Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7910608 2025-03-10 Drug substance, Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 8034946 2025-03-10 Drug product 2018-11-20 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base YUPELRI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REVEFENACIN 175 ug/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G2AE2VE07O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2102779 Internal RxNorm lookup 2102784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49502-806 YUPELRI (REVEFENACIN) SOLUTION [VIATRIS SPECIALTY LLC] 15 Current NDC, Legacy NDC, 8 package rows 20250214_6dfebf04-7c90-436a-9b16-750d3c1ee0a6.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 Units Marketing start Marketing end Sample Exclude flag Status 49502-806-32 49502080632 1 in 1 POUCH Historical 49502-806-33 49502080633 1 in 1 POUCH Historical 49502-806-77 49502080677 7 POUCH in 1 CARTON (49502-806-77) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE 7 pouch 2019-02-22 2021-06-30 No No Current 49502-806-87 49502080687 7 POUCH in 1 CARTON (49502-806-87) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) / 3 mL in 1 VIAL, SINGLE-DOSE 7 pouch 2019-01-01 0000-00-00 Yes No Current 49502-806-93 49502080693 30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 3 mL in 1 VIAL, SINGLE-DOSE 30 pouch 2018-12-03 0000-00-00 No No Current