Duaklir Pressair NDC 70515-001

NDC codes

FDA NDC Directory

Product NDC (as listed)70515-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70515-0001Add 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
70515-001-01	70515000101	1 POUCH in 1 CARTON (70515-001-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALERMarketed from Mar 29, 2019
70515-001-03	70515000103	1 POUCH in 1 CARTON (70515-001-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALERMarketed from Mar 29, 2019

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): Duaklir Pressair
Generic name (nonproprietary): aclidinium bromide and formoterol fumarate
Active ingredients: Aclidinium bromide — 400 ug/1Formoterol fumarate — 12 ug/1
Dosage form: Powder, Metered
Route: Respiratory (Inhalation)
Labeler: Covis Pharma US, Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210595
Marketing start: Mar 29, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 70515-001_2eba3089-28b4-4190-9fba-2511246cfd16SPL ID 2eba3089-28b4-4190-9fba-2511246cfd16SPL set ID 2eba3089-28b4-4190-9fba-2511246cfd16RxCUI 2205094, 2205099, 2205103, 2205104UNII UQW7UF9N91, W34SHF8J2K
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

N470515000101 followed by a unit qualifier and the quantity

Package 70515-0001-01. 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 Aug 1, 2022.

Indications (excerpt from the label)

DUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.4 )] . DUAKLIR PRESSAIR is a combination of aclidinium bromide an anticholinergic, and formoterol fumarate, 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 the relief of acute br…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)