Prescription drug · NDA
Asmanex HFA (Mometasone furoate) NDC 78206-113
Mometasone furoate 200 ug/1 · Aerosol · Respiratory (Inhalation) · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-113-01 | 7820601130178206011301 | 1 CANISTER in 1 CARTON (78206-113-01) / 120 AEROSOL in 1 CANISTERMarketed from Jun 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Asmanex HFA
- Generic name (nonproprietary)
- mometasone furoate
- Active ingredients
- Mometasone furoate — 200 ug/1
- Dosage form
- Aerosol
- Route
- Respiratory (Inhalation)
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205641
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 78206-113_9236ed5b-6c38-451e-ab80-284ac04d5d67SPL ID 9236ed5b-6c38-451e-ab80-284ac04d5d67SPL set ID 0c6d63da-41bc-4894-bead-198e66c848acRxCUI 1536142, 1536144, 1536147, 1536148, 2196790, 2196792UNII 04201GDN4R
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N478206011301followed by a unit qualifier and the quantityPackage 78206-0113-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ASMANEX HFA is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. ( 1.1 ) Important limitations: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma ASMANEX ® HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use ASMANEX HFA is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
About NDC 78206-113
- What is NDC 78206-113?
- 78206-113 is the product NDC for Asmanex HFA (mometasone furoate), Mometasone furoate 200 ug/1 aerosol, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Asmanex HFA (Mometasone furoate).
- What is the active ingredient?
- Mometasone furoate.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Asmanex HFA?
- 2 other product NDCs are listed under this name. See all Asmanex HFA NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Asmanex HFA products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Asmanex HFAmometasone furoate | Mometasone furoate 50 ug/1 | AerosolRespiratory (Inhalation) | Organon LLC | 78206-111 | 78206-0111-01 |
| Asmanex HFAmometasone furoate | Mometasone furoate 100 ug/1 | AerosolRespiratory (Inhalation) | Organon LLC | 78206-112 | 78206-0112-01 |
Other NDCs under NDA 205641
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Asmanex HFAmometasone furoate | Mometasone furoate 50 ug/1 | AerosolRespiratory (Inhalation) | Organon LLC | 78206-111 |
| Asmanex HFAmometasone furoate | Mometasone furoate 100 ug/1 | AerosolRespiratory (Inhalation) | Organon LLC | 78206-112 |