ASMANEX

Product NDC: 0085-1341
Requested package NDC: 0085-1341-07
11-digit product format: 000851341
Labeler code: 0085
Product ID: 0085-1341_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: 220 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0085-1341	0085-1341-07	D	Discontinued by firm		2026-08-17

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	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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
ce567bde-218c-2386-f79b-42addb0c34fb	Product name	2	20180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4	Product name	1	20180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1d	Product name	2	20170613
511188c3-b8c1-4966-aa31-5463cfd4fa48	Product name	1	20141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070	Product name	1	20140508
aca60174-7f12-2753-ec74-0eb827cf0776	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1341-01	EA - Each	0085-1341	b29d20cb-1f65-46ae-9ea9-5c342c37dd6d	1	2012-07-24
0085-1341-02	EA - Each	0085-1341	ab35d487-5377-4936-b654-bfbf3210f80e	1	2012-07-24
0085-1341-03	EA - Each	0085-1341	6438a264-d23e-4838-ac26-355e43db1043	1	2012-07-24
0085-1341-04	EA - Each	0085-1341	fc550e15-6f51-402b-bb78-a5ac5e40013d	1	2012-07-24
0085-1341-06	EA - Each	0085-1341	bfcebecc-df19-4a59-8456-c495a5bb22de	1	2013-09-04
0085-1341-07	EA - Each	0085-1341	37b8be02-e2d4-4544-ad24-946100ccbf3e	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mometasone Furoate	ACTIVE INGREDIENT	04201GDN4R	ASMANEX (MOMETASONE FUROATE) INHALANT [MERCK SHARP & DOHME CORP.]	13
Mometasone	ACTIVE MOIETY	8HR4QJ6DW8	ASMANEX (MOMETASONE FUROATE) INHALANT [MERCK SHARP & DOHME CORP.]	13
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	ASMANEX (MOMETASONE FUROATE) INHALANT [MERCK SHARP & DOHME CORP.]	13
MOMETASONE FUROATE	ACTIVE INGREDIENT	04201GDN4R	ASMANEX (MOMETASONE FUROATE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1
MOMETASONE	ACTIVE MOIETY	8HR4QJ6DW8	ASMANEX (MOMETASONE FUROATE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ASMANEX (MOMETASONE FUROATE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04201GDN4R	MOMETASONE FUROATE	83919-23-7	MOMETASONE FUROATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
746811	Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746813	Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746815	Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746810	mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746812	mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746814	mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746811	14 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]	SBD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746813	30 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]	SBD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746815	60 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]	SBD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746810	14 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler	SCD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746812	30 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler	SCD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746814	60 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler	SCD	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746811	Asmanex 0.2 MG/ACTUAT Dry Powder Inhaler, 14 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746813	Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746815	Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746811	Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746813	Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746815	Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746812	mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746814	mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1
746810	mometasone furoate 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUAT	SY	ba17a773-7f7a-4cc5-9297-359decedfed0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1341-07	00085134107	1 POUCH in 1 CARTON (0085-1341-07) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER	1 pouch	2005-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ASMANEX - Merck Sharp & Dohme Corp.	Merck Sharp & Dohme Corp.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	22
Asmanex - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-10-13	HUMAN PRESCRIPTION DRUG LABEL	1