NDC codes

FDA NDC Directory
Product NDC (as listed)59617-0020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59617-0020Add 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
59617-0020-1596170020011 KIT in 1 CARTON (59617-0020-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOXMarketed from Apr 30, 2014

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Oralair
Generic name (nonproprietary)
anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen
Dosage form
Kit
Labeler
StallergenesNDC labeler code 59617
Product type
Standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 125471
Marketing start
Listing expires
Identifiers
Product ID 59617-0020_37291a56-277d-dd3a-e063-6294a90a7571SPL ID 37291a56-277d-dd3a-e063-6294a90a7571

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

N459617002001 followed by a unit qualifier and the quantity

Package 59617-0020-01. 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

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

About NDC 59617-0020

What is NDC 59617-0020?
59617-0020 is the product NDC for Oralair kit, listed with the FDA by Stallergenes. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oralair (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN).
Who is the labeler?
Stallergenes, NDC labeler code 59617. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oralair?
3 other product NDCs are listed under this name. See all Oralair NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oralair NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitStallergenes59617-002559617-0025-01
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitCENEXI HSC82454-002082454-0020-01
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitCENEXI HSC82454-002582454-0025-01

Other NDCs under BLA 125471

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

FDA NDC Directory listings under BLA 125471
ProductStrengthForm · routeLabelerProduct NDC
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitStallergenes59617-0025
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitCENEXI HSC82454-0020
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen—KitCENEXI HSC82454-0025
Oralair 100 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollenPoa pratensis pollen 100 [IR]/1 + 4 more ingredientsTablet, Orally disintegratingSublingualStallergenes59617-0010
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollenDactylis glomerata pollen 300 [IR]/1 + 4 more ingredientsTablet, Orally disintegratingSublingualStallergenes59617-0015
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollenPoa pratensis pollen 300 [IR]/1 + 4 more ingredientsTablet, Orally disintegratingSublingualStallergenes59617-0016
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollenDactylis glomerata pollen 300 [IR]/1 + 4 more ingredientsTablet, Orally disintegratingSublingualCENEXI HSC82454-0015

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