Prescription drug · NDA AUTHORIZED GENERIC
Umeclidinium Ellipta (Umeclidinium) NDC 66993-189
Umeclidinium bromide 62.5 ug/1 · Aerosol, Powder · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-189-97 | 6699301899766993018997 | 1 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALERMarketed from Apr 6, 2026 |
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)
- Umeclidinium Ellipta
- Generic name (nonproprietary)
- umeclidinium
- Active ingredients
- Umeclidinium bromide — 62.5 ug/1
- Dosage form
- Aerosol, Powder
- Route
- Oral
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 205382
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 66993-189_78029af6-3c01-4be0-8439-ec3c22b4abb7SPL ID 78029af6-3c01-4be0-8439-ec3c22b4abb7SPL set ID 763388a5-cc89-4c25-8562-521df679b7e8RxCUI 1539251UNII 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
N466993018997followed by a unit qualifier and the quantityPackage 66993-0189-97. 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)
Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium 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 66993-189
- What is NDC 66993-189?
- 66993-189 is the product NDC for Umeclidinium Ellipta (umeclidinium), Umeclidinium bromide 62.5 ug/1 aerosol, powder, listed with the FDA by Prasco Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Umeclidinium Ellipta (Umeclidinium).
- What is the active ingredient?
- Umeclidinium bromide.
- Who is the labeler?
- Prasco Laboratories, NDC labeler code 66993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Umeclidinium 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 |
|---|---|---|---|---|
| Incruse Elliptaumeclidinium | Umeclidinium bromide 62.5 ug/1 | Aerosol, PowderOral | GlaxoSmithKline LLC | 0173-0873 |