ASMANEX (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 220 mcg — 120 Dose Inhaler Pouch Carton

NDC 78206-114-01

For Oral Inhalation
Rx only

Asmanex®
Twisthaler®
mometasone furoate inhalation powder

220 mcg per actuation

120 Metered Doses
(For more than 2 inhalations daily)

Discard Twisthaler inhaler 45 days after
opening foil pouch or when dose counter
reads “00”, whichever comes first.

Attention Pharmacist: Detach Patient’s Instructions for Use and dispense with inhaler

PRINCIPAL DISPLAY PANEL -- 220 mcg -- 120 Dose Inhaler Pouch Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 110 mcg — 30 Dose Inhaler Pouch Carton

NDC 78206-115-01

For Oral Inhalation Rx only

Asmanex®
Twisthaler®
mometasone furoate inhalation powder

110 mcg per actuation

Usual Dose for 4 to 11 years of age is 110 mcg

30 Metered Doses

Discard Twisthaler inhaler 45 days after
opening foil pouch or when dose counter
reads “00”, whichever comes first.

Attention Pharmacist: Detach Patient’s Instructions for Use and dispense with inhaler

PRINCIPAL DISPLAY PANEL -- 110 mcg -- 30 Dose Inhaler Pouch Carton
(click image for full-size original)
ASMANEX mometasone furoate inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-114
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mometasone Furoate (Mometasone) Mometasone Furoate 220 ug
Inactive Ingredients
Ingredient Name Strength
Anhydrous Lactose
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-114-03 1 POUCH in 1 CARTON contains a POUCH
1 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-114-03) and contains a INHALER
1 14 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-114-03)
2 NDC:78206-114-04 1 POUCH in 1 CARTON contains a POUCH
2 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-114-04) and contains a INHALER
2 30 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-114-04)
3 NDC:78206-114-02 1 POUCH in 1 CARTON contains a POUCH
3 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-114-02) and contains a INHALER
3 60 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-114-02)
4 NDC:78206-114-01 1 POUCH in 1 CARTON contains a POUCH
4 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-114-01) and contains a INHALER
4 120 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-114-01)
5 NDC:78206-114-59 1 POUCH in 1 CARTON contains a POUCH
5 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-114-59) and contains a INHALER
5 14 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-114-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021067 06/01/2021
ASMANEX mometasone furoate inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-115
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mometasone Furoate (Mometasone) Mometasone Furoate 110 ug
Inactive Ingredients
Ingredient Name Strength
Anhydrous Lactose
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-115-59 1 POUCH in 1 CARTON contains a POUCH
1 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-115-59) and contains a INHALER
1 7 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-115-59)
2 NDC:78206-115-01 1 POUCH in 1 CARTON contains a POUCH
2 1 INHALER in 1 POUCH This package is contained within the CARTON (78206-115-01) and contains a INHALER
2 30 INHALANT in 1 INHALER This package is contained within a POUCH and a CARTON (78206-115-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021067 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 11/2022 Organon LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.