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NDC 78206-0125-59 Dulera 5; 50 ug/1; ug/1 Details
Dulera 5; 50 ug/1; ug/1
Dulera is a RESPIRATORY (INHALATION) AEROSOL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Organon LLC. The primary component is FORMOTEROL FUMARATE; MOMETASONE FUROATE.
MedlinePlus Drug Summary
Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Related Packages: 78206-0125-59Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Formoterol Oral Inhalation
Mometasone oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Mometasone oral inhalation (Asmanex® HFA) is used in adults and children 12 years of age and older. Mometasone powder for oral inhalation (Asmanex® Twisthaler) is used in adults and children 4 years of age and older. It is in a class of medications called corticosteroids. Mometasone works by decreasing swelling and irritation in the airways to allow for easier breathing.
Related Packages: 78206-0125-59Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mometasone Oral Inhalation
Product Information
| NDC | 78206-0125 |
|---|---|
| Product ID | 78206-125_e1839e0b-347d-4ec5-80c9-52aeb21163a6 |
| Associated GPIs | 44209902903210 |
| GCN Sequence Number | 067555 |
| GCN Sequence Number Description | mometasone/formoterol HFA AER AD 50MCG-5MCG INHALATION |
| HIC3 | B63 |
| HIC3 Description | BETA-ADRENERGIC AND GLUCOCORTICOID COMBO, INHALED |
| GCN | 30139 |
| HICL Sequence Number | 037050 |
| HICL Sequence Number Description | MOMETASONE FUROATE/FORMOTEROL FUMARATE |
| Brand/Generic | Brand |
| Proprietary Name | Dulera |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mometasone furoate and formoterol fumarate dihydrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | AEROSOL |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 5; 50 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | FORMOTEROL FUMARATE; MOMETASONE FUROATE |
| Labeler Name | Organon LLC |
| Pharmaceutical Class | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022518 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 78206-0125-59 (78206012559)
| NDC Package Code | 78206-125-59 |
|---|---|
| Billing NDC | 78206012559 |
| Package | 1 CANISTER in 1 CARTON (78206-125-59) / 120 AEROSOL in 1 CANISTER |
| Marketing Start Date | 2021-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |