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 | 7114303750171143037501 | 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Oct 3, 2017 | |
| 71143-375-98 | 7114303759871143037598 | 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.NDC labeler code 71143
- 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
XHANCE is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 ) 1.1 Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. 1.2 Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.
Excerpt only. Read the full label for complete information.
About NDC 71143-375
- What is NDC 71143-375?
- 71143-375 is the product NDC for Xhance (fluticasone propionate), Fluticasone propionate 93 ug/1 spray, metered, listed with the FDA by OptiNose US, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xhance (Fluticasone propionate).
- What is the active ingredient?
- Fluticasone propionate.
- Who is the labeler?
- OptiNose US, Inc., NDC labeler code 71143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xhance?
- 1 other product NDC are listed under this name. See all Xhance NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xhance products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xhancefluticasone propionate | Fluticasone propionate 93 ug/1 | Spray, MeteredNasal | Paratek Pharmaceuticals, Inc. | 71715-003 | 71715-0003-3171715-0003-3271715-0003-33 |
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 |