NDC codes

FDA NDC Directory
Product NDC (as listed)59310-580Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59310-0580Add 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 NDC11-digit (billing)PackageCopy
59310-580-2059310058020593100580201 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALERMarketed from May 11, 2015

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 RespiClick
Generic name (nonproprietary)
albuterol sulfate
Active ingredients
Albuterol sulfate — 90 ug/1
Dosage form
Powder, Metered
Route
Respiratory (Inhalation)
Labeler
Teva Respiratory, LLCNDC labeler code 59310
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 205636
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)
Identifiers
Product ID 59310-580_f34b3a06-6e6b-4011-b93f-107387f94640SPL ID f34b3a06-6e6b-4011-b93f-107387f94640
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

N459310058020 followed by a unit qualifier and the quantity

Package 59310-0580-20. 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.

About NDC 59310-580

What is NDC 59310-580?
59310-580 is the product NDC for ProAir RespiClick (albuterol sulfate), Albuterol sulfate 90 ug/1 powder, metered, listed with the FDA by Teva Respiratory, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ProAir RespiClick (Albuterol Sulfate).
What is the active ingredient?
Albuterol sulfate.
Who is the labeler?
Teva Respiratory, LLC, NDC labeler code 59310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ProAir RespiClick?
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.

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
ProductStrengthForm · routeLabelerProduct NDC
ProAir Digihaleralbuterol sulfateAlbuterol sulfate 90 ug/1InhalantRespiratory (Inhalation)Teva Respiratory, LLC59310-117

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