ASMANEX

Product NDC
78206-114
Requested package NDC
78206-114-59
11-digit product format
782060114
Labeler code
78206
Product ID
78206-114_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
220 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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78206-11478206-114-59DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021067-001ASMANEX TWISTHALERMOMETASONE FUROATE0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30
N021067-002ASMANEX TWISTHALERMOMETASONE FUROATE0.11MG/INHPOWDER / INHALATIONRLD, RS2008-02-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD, RS2008-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD, RS2008-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021067-001ASMANEX TWISTHALER0.22MG/INHPOWDER / INHALATIONRLD, RS2005-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021067-002ASMANEX TWISTHALER0.11MG/INHPOWDER / INHALATIONRLD2008-02-01bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE220 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04201GDN4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
746803Internal RxNorm lookup
746804Internal RxNorm lookup
746810Internal RxNorm lookup
746811Internal RxNorm lookup
746812Internal RxNorm lookup
746813Internal RxNorm lookup
746814Internal RxNorm lookup
746815Internal RxNorm lookup
790283Internal RxNorm lookup
790284Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10b36fb2-6b0d-4f20-b197-3564d6f594b9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-114-01ASMANEX1 in 1 POUCHINHALANT14
78206-114-01ASMANEX1 in 1 CARTONINHALANT14
78206-114-02ASMANEX1 in 1 POUCHINHALANT14
78206-114-02ASMANEX1 in 1 CARTONINHALANT14
78206-114-03ASMANEX1 in 1 CARTONINHALANT14
78206-114-03ASMANEX1 in 1 POUCHINHALANT14
78206-114-04ASMANEX1 in 1 CARTONINHALANT14
78206-114-04ASMANEX1 in 1 POUCHINHALANT14
78206-114-59ASMANEX1 in 1 POUCHINHALANT14
78206-114-59ASMANEX1 in 1 CARTONINHALANT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-114-01EA - Each78206-1148466766e-eb2d-4b53-86e3-6a0add71b91712021-10-08
78206-114-02EA - Each78206-1148ce39d0b-ca2e-4cc3-827f-0cebc33a5da012021-10-08
78206-114-03EA - Each78206-11413037b55-534c-4c51-9763-51cb5559c6fa12021-10-08
78206-114-04EA - Each78206-114d493b26e-e235-46e9-a85b-bf5ff478ec0612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-114ASMANEX (MOMETASONE FUROATE) INHALANT [ORGANON LLC]4Current NDC, Legacy NDC, 10 package rows20250214_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASMANEXMOMETASONE FUROATEOrganon LLC10b36fb2-6b0d-4f20-b197-3564d6f594b92026-07-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 021067
application number: NDA021067
ndc (package): 78206-114-59
ndc (product): 78206-114
ndc11 (package): 78206011459

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
790284Asmanex Twisthaler 110 MCG/INHAL Dry Powder Inhaler, 30 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746804Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746811Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746813Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746815Asmanex Twisthaler 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
790283mometasone furoate 110 MCG/INHAL Dry Powder Inhaler, 30 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746803mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746810mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 14 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746812mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 30 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746814mometasone furoate 220 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN10b36fb2-6b0d-4f20-b197-3564d6f594b94
746804120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]SBD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681114 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]SBD10b36fb2-6b0d-4f20-b197-3564d6f594b94
79028430 ACTUAT mometasone furoate 0.11 MG/ACTUAT Dry Powder Inhaler [Asmanex]SBD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681330 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]SBD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681560 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler [Asmanex]SBD10b36fb2-6b0d-4f20-b197-3564d6f594b94
746803120 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder InhalerSCD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681014 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder InhalerSCD10b36fb2-6b0d-4f20-b197-3564d6f594b94
79028330 ACTUAT mometasone furoate 0.11 MG/ACTUAT Dry Powder InhalerSCD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681230 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder InhalerSCD10b36fb2-6b0d-4f20-b197-3564d6f594b94
74681460 ACTUAT mometasone furoate 0.22 MG/ACTUAT Dry Powder InhalerSCD10b36fb2-6b0d-4f20-b197-3564d6f594b94
746804120 ACTUAT Asmanex 0.22 MG/ACTUAT Dry Powder InhalerSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
79028430 ACTUAT Asmanex 0.11 MG/ACTUAT Dry Powder InhalerSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746811Asmanex 0.2 MG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746813Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746815Asmanex 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
790284Asmanex 110 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746804Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746811Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746813Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746815Asmanex 220 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
790283mometasone furoate 0.11 MG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746803mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 120 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746812mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746814mometasone furoate 0.22 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94
746810mometasone furoate 220 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY10b36fb2-6b0d-4f20-b197-3564d6f594b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-114-59782060114591 POUCH in 1 CARTON (78206-114-59) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER1 pouch2021-06-010000-00-00NoNoCurrent