Prescription drug · NDA
Sinuva (Mometasone furoate) NDC 10599-003
Mometasone furoate 1350 ug/1 · Implant · Intrasinal · Intersect ENT, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10599-003-01 | 10599000301 | 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCHMarketed from Feb 1, 2018 |
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)
- Sinuva
- Generic name (nonproprietary)
- mometasone furoate
- Active ingredients
- Mometasone furoate — 1350 ug/1
- Dosage form
- Implant
- Route
- Intrasinal
- Labeler
- Intersect ENT, Inc.NDC labeler code 10599
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209310
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 10599-003_508796b2-418c-402f-a33f-5766a8d4c18bSPL ID 508796b2-418c-402f-a33f-5766a8d4c18bSPL set ID e33c1b23-cdc6-4f64-94ba-24b0b42c09bfRxCUI 1995983, 1995988UNII 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
N410599000301followed by a unit qualifier and the quantityPackage 10599-0003-01. 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)
SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery. SINUVA Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥ 18years of age who have had ethmoid sinus surgery. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 10599-003
- What is NDC 10599-003?
- 10599-003 is the product NDC for Sinuva (mometasone furoate), Mometasone furoate 1350 ug/1 implant, listed with the FDA by Intersect ENT, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sinuva (Mometasone furoate).
- What is the active ingredient?
- Mometasone furoate.
- Who is the labeler?
- Intersect ENT, Inc., NDC labeler code 10599. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sinuva?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.