What is NDC 59617-0015?

59617-0015 is the product NDC for Oralair 300 IR, Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients tablet, orally disintegrating, listed with the FDA by Stallergenes. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Oralair 300 IR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN).

What is the active ingredient?

Dactylis glomerata pollen, Anthoxanthum odoratum pollen, Lolium perenne pollen, Phleum pratense pollen, Poa pratensis pollen.

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 300 IR?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oralair 300 IR NDC 59617-0015 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59617-0015Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59617-0015Add 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
59617-0015-2	59617001502	30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59617-0015-2)Marketed from Apr 30, 2014
59617-0015-3	59617001503	1 BLISTER PACK in 1 BOX (59617-0015-3) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed 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 300 IRSuffix: 300 IR
Generic name (nonproprietary): anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen
Active ingredients: Dactylis glomerata pollen — 300 [IR]/1Anthoxanthum odoratum pollen — 300 [IR]/1Lolium perenne pollen — 300 [IR]/1Phleum pratense pollen — 300 [IR]/1Poa pratensis pollen — 300 [IR]/1
Dosage form: Tablet, Orally disintegrating
Route: Sublingual
Labeler: StallergenesNDC labeler code 59617
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 125471
Marketing start: Apr 30, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)
Identifiers: Product ID 59617-0015_37291a56-277d-dd3a-e063-6294a90a7571SPL ID 37291a56-277d-dd3a-e063-6294a90a7571
Pharmacologic class: Standardized Pollen Allergenic Extract

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 HCPCS code in Med-Code's directory. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459617001502 followed by a unit qualifier and the quantity

Package 59617-0015-02. 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 59617-0015

What is NDC 59617-0015?: 59617-0015 is the product NDC for Oralair 300 IR, Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients tablet, orally disintegrating, listed with the FDA by Stallergenes. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oralair 300 IR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN).
What is the active ingredient?: Dactylis glomerata pollen, Anthoxanthum odoratum pollen, Lolium perenne pollen, Phleum pratense pollen, 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 300 IR?: 2 other product NDCs are listed under this name. See all Oralair 300 IR 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 300 IR NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen	Poa pratensis pollen 300 [IR]/1 + 4 more ingredients	Tablet, Orally disintegratingSublingual	Stallergenes	59617-0016	59617-0016-01
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen	Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients	Tablet, Orally disintegratingSublingual	CENEXI HSC	82454-0015	82454-0015-0282454-0015-03

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
Product	Strength	Form · route	Labeler	Product NDC
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen	—	Kit	Stallergenes	59617-0020
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen	—	Kit	Stallergenes	59617-0025
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen	—	Kit	CENEXI HSC	82454-0020
Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen	—	Kit	CENEXI HSC	82454-0025
Oralair 100 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen	Poa pratensis pollen 100 [IR]/1 + 4 more ingredients	Tablet, Orally disintegratingSublingual	Stallergenes	59617-0010
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen	Poa pratensis pollen 300 [IR]/1 + 4 more ingredients	Tablet, Orally disintegratingSublingual	Stallergenes	59617-0016
Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen	Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients	Tablet, Orally disintegratingSublingual	CENEXI HSC	82454-0015