ProAir Digihaler (albuterol sulfate) NDC 59310-117

NDC codes

FDA NDC Directory

Product NDC (as listed)59310-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59310-0117Add 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
59310-117-20	59310011720	1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALERMarketed from Oct 4, 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): ProAir Digihaler
Generic name (nonproprietary): albuterol sulfate
Active ingredients: Albuterol sulfate — 90 ug/1
Dosage form: Inhalant
Route: Respiratory (Inhalation)
Labeler: Teva Respiratory, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205636
Marketing start: Oct 4, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 59310-117_2d17c6c3-5021-4444-ad7b-bf0020a9a7e3SPL ID 2d17c6c3-5021-4444-ad7b-bf0020a9a7e3
Pharmacologic class: 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

N459310011720 followed by a unit qualifier and the quantity

Package 59310-0117-20. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 205636

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

FDA NDC Directory listings under NDA 205636
Product	Strength	Form · route	Labeler	Product NDC
ProAir RespiClickalbuterol sulfate	Albuterol sulfate 90 ug/1	Powder, MeteredRespiratory (Inhalation)	Teva Respiratory, LLC	59310-580