Dulera NDC 78206-127

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0127Add 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
78206-127-01	78206012701	1 CANISTER in 1 CARTON (78206-127-01) / 120 AEROSOL in 1 CANISTERMarketed from Jun 1, 2021
78206-127-02	78206012702	1 CANISTER in 1 CARTON (78206-127-02) / 60 AEROSOL in 1 CANISTERMarketed from Jun 1, 2021

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): Dulera
Generic name (nonproprietary): mometasone furoate and formoterol fumarate dihydrate
Active ingredients: Mometasone furoate — 100 ug/1Formoterol fumarate — 5 ug/1
Dosage form: Aerosol
Route: Respiratory (Inhalation)
Labeler: Organon LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022518
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 78206-127_8acf5435-9cbf-4991-b7ef-5e5e7d61220aSPL ID 8acf5435-9cbf-4991-b7ef-5e5e7d61220aSPL set ID 8f399784-f257-4f31-b3dc-368bf2a1864dRxCUI 1246308, 1246310, 1246311, 1246313, 1660933, 1660934, 1660937, 1660938, 2196590, 2196592UNII 04201GDN4R, W34SHF8J2K
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

N478206012701 followed by a unit qualifier and the quantity

Package 78206-0127-01. 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 Jul 10, 2026.

Indications (excerpt from the label)

DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. ( 1.1 ) Important Limitation of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use: DULERA …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022518

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

FDA NDC Directory listings under NDA 022518
Product	Strength	Form · route	Labeler	Product NDC
Duleramometasone furoate and formoterol fumarate dihydrate	Mometasone furoate 200 ug/1; Formoterol fumarate 5 ug/1	AerosolRespiratory (Inhalation)	Organon LLC	78206-126
Duleramometasone furoate and formoterol fumarate dihydrate	Mometasone furoate 50 ug/1; Formoterol fumarate 5 ug/1	AerosolRespiratory (Inhalation)	Organon LLC	78206-125