NDC codes

FDA NDC Directory
Product NDC (as listed)66993-135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0135Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
66993-135-9766993013597669930135971 TRAY in 1 CARTON (66993-135-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALERMarketed from May 23, 2022

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)
Fluticasone Furoate and Vilanterol
Generic name (nonproprietary)
fluticasone furoate and vilanterol
Active ingredients
Fluticasone furoate — 100 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 204275
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 66993-135_cdb395b6-2cfd-43d5-affa-68ce02b77312SPL ID cdb395b6-2cfd-43d5-affa-68ce02b77312SPL set ID 3a761487-c300-451a-8537-3196c00c11b5RxCUI 1424889, 1648788UNII JS86977WNV, 40AHO2C6DG
Pharmacologic class
Corticosteroid; 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

N466993013597 followed by a unit qualifier and the quantity

Package 66993-0135-97. 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)

Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) • the maintenance treatment of asthma in patients aged 5 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). 1.2 Maintenance Treatment of Asthma Fluticasone…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66993-135

What is NDC 66993-135?
66993-135 is the product NDC for Fluticasone Furoate and Vilanterol, Fluticasone furoate 100 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?
Fluticasone Furoate and Vilanterol.
What is the active ingredient?
Fluticasone furoate, 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 Fluticasone Furoate and Vilanterol?
1 other product NDC are listed under this name. See all Fluticasone Furoate and Vilanterol NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluticasone Furoate and Vilanterol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fluticasone Furoate and VilanterolFluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1PowderRespiratory (Inhalation)Prasco Laboratories66993-13666993-0136-97

Other NDCs under NDA 204275

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204275
ProductStrengthForm · routeLabelerProduct NDC
Breo Elliptafluticasone furoate and vilanterol trifenatateFluticasone furoate 100 ug/1; Vilanterol trifenatate 25 ug/1PowderRespiratory (Inhalation)GlaxoSmithKline LLC0173-0859
Breo Elliptafluticasone furoate and vilanterol trifenatateFluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1PowderRespiratory (Inhalation)GlaxoSmithKline LLC0173-0882
Breo Elliptafluticasone furoate and vilanterol trifenatateFluticasone furoate 50 ug/1; Vilanterol trifenatate 25 ug/1PowderRespiratory (Inhalation)GlaxoSmithKline LLC0173-0916
Fluticasone Furoate and VilanterolFluticasone furoate 200 ug/1; Vilanterol trifenatate 25 ug/1PowderRespiratory (Inhalation)Prasco Laboratories66993-136

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