Prescription drug · NDA
Xhance (fluticasone propionate) NDC 71143-375
Fluticasone propionate 93 ug/1 · Spray, Metered · Nasal · OptiNose US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71143-375-01 | 71143037501 | 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Oct 3, 2017 | |
| 71143-375-98 | 71143037598 | 1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLEMarketed from Mar 1, 2019 · Sample package |
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)
- Xhance
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 93 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- OptiNose US, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209022
- Marketing start
- Marketing end
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71143-375_4650025f-0f79-6a7b-e063-6294a90ab7f6SPL ID 4650025f-0f79-6a7b-e063-6294a90ab7f6SPL set ID c79bbb9f-e483-4093-8c92-ea978e7bf278RxCUI 1946583, 1946589UNII O2GMZ0LF5WUPC 0371143375011
- 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471143037501followed by a unit qualifier and the quantityPackage 71143-0375-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 209022
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 |
|---|---|---|---|---|
| Xhancefluticasone propionate | Fluticasone propionate 93 ug/1 | Spray, MeteredNasal | Paratek Pharmaceuticals, Inc. | 71715-003 |