Prescription drug · NDA
Incruse Ellipta (Umeclidinium) NDC 0173-0873
Umeclidinium bromide 62.5 ug/1 · Aerosol, Powder · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0873-06 | 0017308730600173087306 | 1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALERMarketed from Apr 30, 2014 | |
| 0173-0873-10 | 0017308731000173087310 | 1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALERMarketed from Apr 30, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Incruse Ellipta
- Generic name (nonproprietary)
- umeclidinium
- Active ingredients
- Umeclidinium bromide — 62.5 ug/1
- Dosage form
- Aerosol, Powder
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205382
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415fSPL ID 4049ca45-7739-4d4a-bcce-50c5b3c7415fSPL set ID dbb64747-1505-49d7-9a33-99dd402e96d3RxCUI 1539251, 1539885, 1596444, 1596445UNII 7AN603V4JV
- Pharmacologic class
- Anticholinergic
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400173087306followed by a unit qualifier and the quantityPackage 00173-0873-06. 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)
INCRUSE ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0173-0873
- What is NDC 0173-0873?
- 0173-0873 is the product NDC for Incruse Ellipta (umeclidinium), Umeclidinium bromide 62.5 ug/1 aerosol, powder, listed with the FDA by GlaxoSmithKline LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Incruse Ellipta (Umeclidinium).
- What is the active ingredient?
- Umeclidinium bromide.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Incruse Ellipta?
- 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.
Other NDCs under NDA 205382
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 |
|---|---|---|---|---|
| Umeclidinium Elliptaumeclidinium | Umeclidinium bromide 62.5 ug/1 | Aerosol, PowderOral | Prasco Laboratories | 66993-189 |