fluticasone propionate and salmeterol NDC 0093-7516

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-7516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-7516Add 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 NDC	11-digit (billing)	Package	Copy
0093-7516-31	00093751631	1 POUCH in 1 CARTON (0093-7516-31) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALERMarketed from Mar 23, 2022

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): fluticasone propionate and salmeterol
Generic name (nonproprietary): fluticasone propionate and salmeterol
Active ingredients: Fluticasone propionate — 500 ug/1Salmeterol xinafoate — 50 ug/1
Dosage form: Powder
Route: Respiratory (Inhalation)
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213948
Marketing start: Mar 23, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0093-7516_2c0a7e7d-224f-4fd8-abf1-05f65fb12f5bSPL ID 2c0a7e7d-224f-4fd8-abf1-05f65fb12f5bSPL set ID ce347bf4-4cc1-46dc-b5f1-6f8ff48da84bRxCUI 896184, 896209, 896228UNII 6EW8Q962A5, O2GMZ0LF5W
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

N400093751631 followed by a unit qualifier and the quantity

Package 00093-7516-31. 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 Sep 28, 2022.

Indications (excerpt from the label)

Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma Fluticasone propionate and salmeterol inhalation powder is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Fluticasone propionate and salmeterol inhalat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213948

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

FDA NDC Directory listings under ANDA 213948
Product	Strength	Form · route	Labeler	Product NDC
fluticasone propionate and salmeterol	Fluticasone propionate 100 ug/1; Salmeterol xinafoate 50 ug/1	PowderRespiratory (Inhalation)	Teva Pharmaceuticals USA, Inc.	0093-7517
fluticasone propionate and salmeterol	Fluticasone propionate 250 ug/1; Salmeterol xinafoate 50 ug/1	PowderRespiratory (Inhalation)	Teva Pharmaceuticals USA, Inc.	0093-7518