FDA.reportPublic FDA data

ASMANEX

Product NDC
78206-115
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

Additional Listing Data#

Finished product
Yes
Brand name base
ASMANEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE110 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui746803, 746804, 746810, 746811, 746812, 746813, 746814, 746815, 790283, 790284

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
78206-115-01ASMANEX1 in 1 POUCHINHALANT14
78206-115-01ASMANEX1 in 1 CARTONINHALANT14
78206-115-59ASMANEX1 in 1 POUCHINHALANT14
78206-115-59ASMANEX1 in 1 CARTONINHALANT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-115-01EA - Each78206-1150bcae80e-9f6c-4e3b-8507-4c7da908198112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-115ASMANEX (MOMETASONE FUROATE) INHALANT [ORGANON LLC]4Current NDC, Legacy NDC, 4 package rows20250214_10b36fb2-6b0d-4f20-b197-3564d6f594b9.zip

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
78206-115-01782060115011 POUCH in 1 CARTON (78206-115-01) / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALER1 pouch2021-06-010000-00-00NoNoCurrent
78206-115-59782060115591 POUCH in 1 CARTON (78206-115-59) / 1 INHALER in 1 POUCH / 7 INHALANT in 1 INHALER1 pouch2021-06-010000-00-00NoNoCurrent