Home NDC 78206-115-59 ASMANEX
Product NDC 78206-115
Requested package NDC 78206-115-59
11-digit product format 782060115
Labeler code 78206
Product ID 78206-115_4742e310-f27e-4c57-97d2-29034ed8bea8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler Organon LLC
Application NDA021067
Marketing category NDA
Marketing start 2021-06-01
Substance MOMETASONE FUROATE
Active strength 110 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 42 .
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 N021067-001 ASMANEX TWISTHALER MOMETASONE FUROATE 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 N021067-002 ASMANEX TWISTHALER MOMETASONE FUROATE 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01
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 · 84 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 2026-08-18 06:07:40 2026-07 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD, RS 2008-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021067-001 ASMANEX TWISTHALER 0.22MG/INH POWDER / INHALATION RLD, RS 2005-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021067-002 ASMANEX TWISTHALER 0.11MG/INH POWDER / INHALATION RLD 2008-02-01 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base ASMANEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE 110 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04201GDN4R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 746803 Internal RxNorm lookup 746804 Internal RxNorm lookup 746810 Internal RxNorm lookup 746811 Internal RxNorm lookup 746812 Internal RxNorm lookup 746813 Internal RxNorm lookup 746814 Internal RxNorm lookup 746815 Internal RxNorm lookup 790283 Internal RxNorm lookup 790284 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-115-01 ASMANEX 1 in 1 POUCH INHALANT 1 4 78206-115-01 ASMANEX 1 in 1 CARTON INHALANT 1 4 78206-115-59 ASMANEX 1 in 1 POUCH INHALANT 1 4 78206-115-59 ASMANEX 1 in 1 CARTON INHALANT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-115 ASMANEX (MOMETASONE FUROATE) INHALANT [ORGANON LLC] 4 Current NDC, Legacy NDC, 4 package rows 20250214_10b36fb2-6b0d-4f20-b197-3564d6f594b9.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 790284 Asmanex Twisthaler 110 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746804 Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746811 Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746813 Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746815 Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790283 mometasone furoate 110 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746803 mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746810 mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746812 mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746814 mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT PSN 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746804 120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex] SBD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746811 14 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex] SBD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790284 30 ACTUAT mometasone furoate 0.11 MG/ACTUAT Dry Powder Inhaler [Asmanex] SBD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746813 30 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex] SBD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746815 60 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex] SBD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746803 120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler SCD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746810 14 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler SCD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790283 30 ACTUAT mometasone furoate 0.11 MG/ACTUAT Dry Powder Inhaler SCD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746812 30 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler SCD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746814 60 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler SCD 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746804 120 ACTUAT Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790284 30 ACTUAT Asmanex 0.11 MG/ACTUAT Dry Powder Inhaler SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746811 Asmanex 0.2 MG/ACTUAT Dry Powder Inhaler, 14 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746813 Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746815 Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790284 Asmanex 110 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746804 Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746811 Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746813 Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746815 Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 790283 mometasone furoate 0.11 MG/ACTUAT Dry Powder Inhaler, 30 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746803 mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 120 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746812 mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746814 mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4 746810 mometasone furoate 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUAT SY 10b36fb2-6b0d-4f20-b197-3564d6f594b9 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78206-115-59 78206011559 1 POUCH in 1 CARTON (78206-115-59) / 1 INHALER in 1 POUCH / 7 INHALANT in 1 INHALER 1 pouch 2021-06-01 0000-00-00 No No Current