What is NDC 70515-002?

70515-002 is the product NDC for Tudorza Pressair (aclidinium bromide), Aclidinium bromide 400 ug/1 powder, metered, listed with the FDA by Covis Pharma US, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Covis Pharma US, Inc, NDC labeler code 70515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tudorza Pressair?

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.

Tudorza Pressair NDC 70515-002 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70515-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70515-0002Add 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
70515-002-01	70515000201	1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALERMarketed from Jul 1, 2015
70515-002-02	70515000202	1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALERMarketed from Jul 1, 2015
70515-002-03	70515000203	1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALERMarketed from Jul 1, 2015 · Sample package

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): Tudorza Pressair
Generic name (nonproprietary): aclidinium bromide
Active ingredients: Aclidinium bromide — 400 ug/1
Dosage form: Powder, Metered
Route: Respiratory (Inhalation)
Labeler: Covis Pharma US, IncNDC labeler code 70515
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202450
Marketing start: Jul 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 70515-002_86a2e74d-bbf7-4de6-af00-3d23ee80630aSPL ID 86a2e74d-bbf7-4de6-af00-3d23ee80630aSPL set ID 6f92cceb-a63f-4470-99b6-56179d98f10fRxCUI 1303102, 1303107, 1607111, 1607112UNII UQW7UF9N91
Pharmacologic class: Anticholinergic

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

N470515000201 followed by a unit qualifier and the quantity

Package 70515-0002-01. 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)

TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70515-002

What is NDC 70515-002?: 70515-002 is the product NDC for Tudorza Pressair (aclidinium bromide), Aclidinium bromide 400 ug/1 powder, metered, listed with the FDA by Covis Pharma US, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tudorza Pressair (Aclidinium bromide).
What is the active ingredient?: Aclidinium bromide.
Who is the labeler?: Covis Pharma US, Inc, NDC labeler code 70515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tudorza Pressair?: 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.

Tudorza Pressair (Aclidinium bromide) NDC 70515-002