ASMANEX HFA

Product NDC: 78206-111
11-digit product format: 782060111
Labeler code: 78206
Product ID: 78206-111_75a83fa4-9a71-4e19-bcff-20dcd0101980
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOMETASONE FUROATE
Dosage form: AEROSOL
Route: RESPIRATORY (INHALATION)
Labeler: Organon LLC
Application: NDA205641
Marketing category: NDA
Marketing start: 2021-06-01
Substance: MOMETASONE FUROATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	78206-111	78206-111-59	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205641-001	ASMANEX HFA	MOMETASONE FUROATE	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25
N205641-002	ASMANEX HFA	MOMETASONE FUROATE	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25
N205641-003	ASMANEX HFA	MOMETASONE FUROATE	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12

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 4 · 125 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	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-002	ASMANEX HFA	0.20MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2014-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205641-003	ASMANEX HFA	0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205641-001	ASMANEX HFA	0.10MG/INH	AEROSOL, METERED / INHALATION	RLD	2014-04-25	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205641-003	NS	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205641-003	PED	2023-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205641-003	NS	2022-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205641-003	PED	2023-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205641-003	NS	2022-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205641-003	PED	2023-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N205641-003	NS	2022-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205641-003	PED	2023-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205641-003	NS	2022-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205641-003	PED	2023-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205641-003	NS	2022-08-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205641-003	PED	2023-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205641-003	NS	2022-08-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205641-003	PED	2023-02-12	`5aa47cf7b7d7…`
2023-12-20 04:57 UTC	2023-12	N205641-003	PED	2023-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205641-003	PED	2023-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205641-003	PED	2023-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205641-003	PED	2023-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205641-003	PED	2023-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205641-003	PED	2023-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205641-003	NS	2022-08-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205641-003	PED	2023-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205641-003	NS	2022-08-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205641-003	PED	2023-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205641-003	NS	2022-08-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205641-003	PED	2023-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205641-003	NS	2022-08-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N205641-003	PED	2023-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205641-003	NS	2022-08-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205641-003	PED	2023-02-12	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ASMANEX HFA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MOMETASONE FUROATE	50 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1536142	Internal RxNorm lookup
1536144	Internal RxNorm lookup
1536147	Internal RxNorm lookup
1536148	Internal RxNorm lookup
2196790	Internal RxNorm lookup
2196792	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c6d63da-41bc-4894-bead-198e66c848ac	Available on FDA.report

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78206-111-01	ASMANEX HFA	120 in 1 CANISTER	AEROSOL	120	7
78206-111-01	ASMANEX HFA	1 in 1 CARTON	AEROSOL	1	7
78206-111-59	ASMANEX HFA	1 in 1 CARTON	AEROSOL	1	7
78206-111-59	ASMANEX HFA	120 in 1 CANISTER	AEROSOL	120	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-111-01	GM - Gram	78206-111	293a09c9-14c5-485b-aadd-f212d984f342	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-111	ASMANEX HFA (MOMETASONE FUROATE) AEROSOL [ORGANON LLC]	4	Current NDC, Legacy NDC, 4 package rows	20241121_0c6d63da-41bc-4894-bead-198e66c848ac.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASMANEX HFA	MOMETASONE FUROATE	Organon LLC	0c6d63da-41bc-4894-bead-198e66c848ac	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205641 application number: NDA205641 ndc (product): 78206-111

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
1536144	Asmanex HFA 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536148	Asmanex HFA 200 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196792	Asmanex HFA 50 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536142	mometasone furoate 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536147	mometasone furoate 200 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196790	mometasone furoate 50 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT	PSN	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196792	120 ACTUAT mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler [Asmanex]	SBD	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536144	120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Asmanex]	SBD	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536148	120 ACTUAT mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Asmanex]	SBD	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196790	120 ACTUAT mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler	SCD	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536142	120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler	SCD	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536147	120 ACTUAT mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler	SCD	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196792	120 ACTUAT Asmanex 0.05 MG/ACTUAT Metered Dose Inhaler	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536142	120 ACTUAT mometasone furoate 100 MCG/ACTUAT Metered Dose Inhaler	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536147	120 ACTUAT mometasone furoate 200 MCG/ACTUAT Metered Dose Inhaler	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536148	Asmanex 0.2 MG/ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196792	Asmanex HFA 0.05 MG/ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536144	Asmanex HFA 0.1 MG/ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536144	Asmanex HFA 100 MCG Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
1536148	Asmanex HFA 200 MCG Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7
2196792	Asmanex HFA 50 MCG Metered Dose Inhaler, 120 ACTUAT	SY	0c6d63da-41bc-4894-bead-198e66c848ac	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-111-01	78206011101	1 CANISTER in 1 CARTON (78206-111-01) / 120 AEROSOL in 1 CANISTER	1 canister	2021-06-01	0000-00-00	No	No	Current
78206-111-59	78206011159	1 CANISTER in 1 CARTON (78206-111-59) / 120 AEROSOL in 1 CANISTER	1 canister	2021-06-01	0000-00-00	No	No	Current