NDC codes

FDA NDC Directory
Product NDC (as listed)10599-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10599-0003Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
10599-003-01105990003011 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

N410599000301 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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