Prescription drug · NDA AUTHORIZED GENERIC
Umeclidinium and Vilanterol Ellipta NDC 66993-134
umeclidinium bromide and vilanterol trifenatate · Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1 · Powder · Respiratory (Inhalation) · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-134-97 | 6699301349766993013497 | 1 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from Apr 11, 2025 |
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 and Vilanterol Ellipta
- Generic name (nonproprietary)
- umeclidinium bromide and vilanterol trifenatate
- Active ingredients
- Umeclidinium bromide — 62.5 ug/1Vilanterol trifenatate — 25 ug/1
- Dosage form
- Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 203975
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 66993-134_bffa73f4-99ab-49a2-b585-0982dd611110SPL ID bffa73f4-99ab-49a2-b585-0982dd611110SPL set ID 6de414b1-f707-4b98-9e4b-742032ec90afRxCUI 1487527UNII 7AN603V4JV, 40AHO2C6DG
- Pharmacologic class
- Anticholinergic; beta2-Adrenergic Agonist
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N466993013497followed by a unit qualifier and the quantityPackage 66993-0134-97. 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 and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use Umeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of Umeclidinium and Vilanterol ELLIPTA in asthma have not been established. Umeclidinium and Vilanterol ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 ) Limitations of Use: Not indicated for relief of …
Excerpt only. Read the full label for complete information.
About NDC 66993-134
- What is NDC 66993-134?
- 66993-134 is the product NDC for Umeclidinium and Vilanterol Ellipta, Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1 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 and Vilanterol Ellipta (Umeclidinium bromide and vilanterol trifenatate).
- What is the active ingredient?
- Umeclidinium bromide, Vilanterol trifenatate.
- 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 and Vilanterol 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 203975
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 |
|---|---|---|---|---|
| Anoro Elliptaumeclidinium bromide and vilanterol trifenatate | Umeclidinium bromide 62.5 ug/1; Vilanterol trifenatate 25 ug/1 | PowderRespiratory (Inhalation) | GlaxoSmithKline LLC | 0173-0869 |