Home NDC 0085-1461-06 ASMANEX
Product NDC 0085-1461
Requested package NDC 0085-1461-06
11-digit product format 000851461
Labeler code 0085
Product ID 0085-1461_22ce7e61-648f-4680-b024-f35096bf5d82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler Merck Sharp & Dohme Corp.
Application NDA021067
Marketing category NDA
Marketing start 2005-03-30
Marketing end 0000-00-00
Substance MOMETASONE FUROATE
Active strength 110 ug/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 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…
DailyMed Socrata Ingredients# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ASMANEX MOMETASONE FUROATE Organon LLC 10b36fb2-6b0d-4f20-b197-3564d6f594b9 2026-07-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 021067 application number: NDA021067
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0085-1461-06 00085146106 1 POUCH in 1 CARTON (0085-1461-06) > 1 INHALER in 1 POUCH > 7 INHALANT in 1 INHALER 1 pouch 2005-03-30 0000-00-00 No No Current