Prescription drug · NDA
Asmanex (Mometasone furoate) NDC 78206-115
Mometasone furoate 110 ug/1 · Inhalant · Respiratory (Inhalation) · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-115-01 | 7820601150178206011501 | 1 POUCH in 1 CARTON (78206-115-01) / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALERMarketed 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
- Generic name (nonproprietary)
- mometasone furoate
- Active ingredients
- Mometasone furoate — 110 ug/1
- Dosage form
- Inhalant
- Route
- Respiratory (Inhalation)
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021067
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 78206-115_5c02ae9b-33e2-405a-bdd6-aad47f5d2d5cSPL ID 5c02ae9b-33e2-405a-bdd6-aad47f5d2d5cSPL set ID 10b36fb2-6b0d-4f20-b197-3564d6f594b9RxCUI 746803, 746804, 746810, 746811, 746812, 746813, 746814, 746815, 790283, 790284UNII 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
N478206011501followed by a unit qualifier and the quantityPackage 78206-0115-01. 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 ® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age. ASMANEX TWISTHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. ( 1 ) Limitations of Use: ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm ( 1 , 5.2 ) or in children less than 4 years of age ( 1 , 8.4 ).
Excerpt only. Read the full label for complete information.
About NDC 78206-115
- What is NDC 78206-115?
- 78206-115 is the product NDC for Asmanex (mometasone furoate), Mometasone furoate 110 ug/1 inhalant, 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 (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?
- 1 other product NDC are listed under this name. See all Asmanex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Asmanex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Asmanexmometasone furoate | Mometasone furoate 220 ug/1 | InhalantRespiratory (Inhalation) | Organon LLC | 78206-114 | 78206-0114-0178206-0114-0278206-0114-03+1 more |
Other NDCs under NDA 021067
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 |
|---|---|---|---|---|
| Asmanexmometasone furoate | Mometasone furoate 220 ug/1 | InhalantRespiratory (Inhalation) | Organon LLC | 78206-114 |