FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui1536142, 1536144, 1536147, 1536148, 2196790, 2196792

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
78206-111-01ASMANEX HFA120 in 1 CANISTERAEROSOL1207
78206-111-01ASMANEX HFA1 in 1 CARTONAEROSOL17
78206-111-59ASMANEX HFA1 in 1 CARTONAEROSOL17
78206-111-59ASMANEX HFA120 in 1 CANISTERAEROSOL1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-111-01GM - Gram78206-111293a09c9-14c5-485b-aadd-f212d984f34212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-111ASMANEX HFA (MOMETASONE FUROATE) AEROSOL [ORGANON LLC]4Current NDC, Legacy NDC, 4 package rows20241121_0c6d63da-41bc-4894-bead-198e66c848ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536144Asmanex HFA 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
1536148Asmanex HFA 200 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
2196792Asmanex HFA 50 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
1536142mometasone furoate 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
1536147mometasone furoate 200 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
2196790mometasone furoate 50 MCG/INHAL Metered Dose Inhaler, 120 ACTUATPSN0c6d63da-41bc-4894-bead-198e66c848ac7
2196792120 ACTUAT mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler [Asmanex]SBD0c6d63da-41bc-4894-bead-198e66c848ac7
1536144120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Asmanex]SBD0c6d63da-41bc-4894-bead-198e66c848ac7
1536148120 ACTUAT mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Asmanex]SBD0c6d63da-41bc-4894-bead-198e66c848ac7
2196790120 ACTUAT mometasone furoate 0.05 MG/ACTUAT Metered Dose InhalerSCD0c6d63da-41bc-4894-bead-198e66c848ac7
1536142120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose InhalerSCD0c6d63da-41bc-4894-bead-198e66c848ac7
1536147120 ACTUAT mometasone furoate 0.2 MG/ACTUAT Metered Dose InhalerSCD0c6d63da-41bc-4894-bead-198e66c848ac7
2196792120 ACTUAT Asmanex 0.05 MG/ACTUAT Metered Dose InhalerSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536142120 ACTUAT mometasone furoate 100 MCG/ACTUAT Metered Dose InhalerSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536147120 ACTUAT mometasone furoate 200 MCG/ACTUAT Metered Dose InhalerSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536148Asmanex 0.2 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7
2196792Asmanex HFA 0.05 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536144Asmanex HFA 0.1 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536144Asmanex HFA 100 MCG Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7
1536148Asmanex HFA 200 MCG Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7
2196792Asmanex HFA 50 MCG Metered Dose Inhaler, 120 ACTUATSY0c6d63da-41bc-4894-bead-198e66c848ac7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-111-01782060111011 CANISTER in 1 CARTON (78206-111-01) / 120 AEROSOL in 1 CANISTER1 canister2021-06-010000-00-00NoNoCurrent
78206-111-59782060111591 CANISTER in 1 CARTON (78206-111-59) / 120 AEROSOL in 1 CANISTER1 canister2021-06-010000-00-00NoNoCurrent