sinuva

Generic: mometasone furoate

Labeler: intersect ent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sinuva
Generic Name mometasone furoate
Labeler intersect ent, inc.
Dosage Form IMPLANT
Routes
INTRASINAL
Active Ingredients

mometasone furoate 1350 ug/1

Manufacturer
Intersect ENT, Inc.

Identifiers & Regulatory

Product NDC 10599-003
Product ID 10599-003_508796b2-418c-402f-a33f-5766a8d4c18b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209310
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10599003
Hyphenated Format 10599-003

Supplemental Identifiers

RxCUI
1995983 1995988
UNII
04201GDN4R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sinuva (source: ndc)
Generic Name mometasone furoate (source: ndc)
Application Number NDA209310 (source: ndc)
Routes
INTRASINAL
source: ndc

Resolved Composition

Strengths
  • 1350 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH
source: ndc

Packages (1)

10599-003-01 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH

Ingredients (1)

mometasone furoate (1350 ug/1)

Linked Drug Pages (1)

Sinuva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRASINAL"], "spl_id": "508796b2-418c-402f-a33f-5766a8d4c18b", "openfda": {"unii": ["04201GDN4R"], "rxcui": ["1995983", "1995988"], "spl_set_id": ["e33c1b23-cdc6-4f64-94ba-24b0b42c09bf"], "manufacturer_name": ["Intersect ENT, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (10599-003-01)  / 1 IMPLANT in 1 POUCH", "package_ndc": "10599-003-01", "marketing_start_date": "20180201"}], "brand_name": "Sinuva", "product_id": "10599-003_508796b2-418c-402f-a33f-5766a8d4c18b", "dosage_form": "IMPLANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "10599-003", "generic_name": "mometasone furoate", "labeler_name": "Intersect ENT, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sinuva", "active_ingredients": [{"name": "MOMETASONE FUROATE", "strength": "1350 ug/1"}], "application_number": "NDA209310", "marketing_category": "NDA", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}