What is NDC 65044-0612?

65044-0612 is the product NDC for Standardized Grass Pollen, Fescue, Meadow, Lolium pratense pollen 100000 [BAU]/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Jubilant HollisterStier LLC, NDC labeler code 65044. 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 Grass Pollen, Fescue, Meadow?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Standardized Grass Pollen, Fescue, Meadow NDC 65044-0612

NDC codes

FDA NDC Directory

Product NDC (as listed)65044-0612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65044-0612Add 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
65044-0612-1	65044061201	5 mL in 1 VIAL (65044-0612-1)Marketed from Jan 15, 1998
65044-0612-2	65044061202	10 mL in 1 VIAL (65044-0612-2)Marketed from Jan 15, 1998
65044-0612-3	65044061203	30 mL in 1 VIAL (65044-0612-3)Marketed from Jan 15, 1998
65044-0612-4	65044061204	50 mL in 1 VIAL (65044-0612-4)Marketed from Jan 15, 1998

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): Standardized Grass Pollen, Fescue, Meadow
Generic name (nonproprietary): standardized grass pollen, fescue, meadow
Active ingredients: Lolium pratense pollen — 100000 [BAU]/mL
Dosage form: Injection, Solution
Route: Percutaneous, Subcutaneous
Labeler: Jubilant HollisterStier LLCNDC labeler code 65044
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 103874
Marketing start: Jan 15, 1998
Listing expires: Dec 31, 2027
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 65044-0612_3c14e8ca-64c9-463f-963d-5a2e31d01ad3SPL ID 3c14e8ca-64c9-463f-963d-5a2e31d01ad3
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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465044061201 followed by a unit qualifier and the quantity

Package 65044-0612-01. 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 65044-0612

What is NDC 65044-0612?: 65044-0612 is the product NDC for Standardized Grass Pollen, Fescue, Meadow, Lolium pratense pollen 100000 [BAU]/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Standardized Grass Pollen, Fescue, Meadow.
What is the active ingredient?: Lolium pratense pollen.
Who is the labeler?: Jubilant HollisterStier LLC, NDC labeler code 65044. 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 Grass Pollen, Fescue, Meadow?: 1 other product NDC are listed under this name. See all Standardized Grass Pollen, Fescue, Meadow 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 Standardized Grass Pollen, Fescue, Meadow NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Standardized Grass Pollen, Fescue, Meadow	Lolium pratense pollen 10000 [BAU]/mL	Injection, SolutionPercutaneous, Subcutaneous	Jubilant HollisterStier LLC	65044-0611	65044-0611-0165044-0611-0265044-0611-03+1 more

Other NDCs under BLA 103874

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

FDA NDC Directory listings under BLA 103874
Product	Strength	Form · route	Labeler	Product NDC
Standardized Grass Pollen, Fescue, Meadow	Lolium pratense pollen 10000 [BAU]/mL	Injection, SolutionPercutaneous, Subcutaneous	Jubilant HollisterStier LLC	65044-0611