What is NDC 0268-3509?

0268-3509 is the product NDC for Standardized Perennial Rye Grass Pollen, Lolium perenne pollen 100000 [BAU]/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Standardized Perennial Rye Grass Pollen (Lolium perenne pollen).

ALK-Abello, Inc., NDC labeler code 0268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Standardized Perennial Rye Grass Pollen?

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.

Standardized Perennial Rye Grass Pollen NDC 0268-3509

NDC codes

FDA NDC Directory

Product NDC (as listed)0268-3509Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00268-3509Add 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
0268-3509-06	00268350906	5 mL in 1 VIAL, MULTI-DOSE (0268-3509-06)Marketed from Dec 18, 1997

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Standardized Perennial Rye Grass Pollen
Generic name (nonproprietary): lolium perenne pollen
Active ingredients: Lolium perenne pollen — 100000 [BAU]/mL
Dosage form: Injection, Solution
Route: Percutaneous
Labeler: ALK-Abello, Inc.NDC labeler code 0268
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 103056
Marketing start: Dec 18, 1997
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)
Identifiers: Product ID 0268-3509_2e2db5ce-9bd5-4ad3-94c0-45e59370fb28SPL ID 2e2db5ce-9bd5-4ad3-94c0-45e59370fb28
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 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

N400268350906 followed by a unit qualifier and the quantity

Package 00268-3509-06. 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 0268-3509

What is NDC 0268-3509?: 0268-3509 is the product NDC for Standardized Perennial Rye Grass Pollen, Lolium perenne pollen 100000 [BAU]/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Standardized Perennial Rye Grass Pollen (Lolium perenne pollen).
What is the active ingredient?: Lolium perenne pollen.
Who is the labeler?: ALK-Abello, Inc., NDC labeler code 0268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Standardized Perennial Rye Grass Pollen?: 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 BLA 103056

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

FDA NDC Directory listings under BLA 103056
Product	Strength	Form · route	Labeler	Product NDC
Rye Grass, Perennial Standardized	Lolium perenne pollen 100000 [BAU]/mL	Injection, SolutionSubcutaneous	ALK-Abello, Inc.	0268-0289

Standardized Perennial Rye Grass Pollen (Lolium perenne pollen) NDC 0268-3509