Standardized Grass Pollen, Redtop NDC 65044-0778

NDC codes

FDA NDC Directory

Product NDC (as listed)65044-0778Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65044-0778Add 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
65044-0778-1	65044077801	5 mL in 1 VIAL (65044-0778-1)Marketed from Jan 15, 1998
65044-0778-2	65044077802	10 mL in 1 VIAL (65044-0778-2)Marketed from Jan 15, 1998
65044-0778-3	65044077803	30 mL in 1 VIAL (65044-0778-3)Marketed from Jan 15, 1998
65044-0778-4	65044077804	50 mL in 1 VIAL (65044-0778-4)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, Redtop
Generic name (nonproprietary): standardized grass pollen, redtop
Active ingredients: Agrostis gigantea pollen — 100000 [BAU]/mL
Dosage form: Injection, Solution
Route: Percutaneous, Subcutaneous
Labeler: Jubilant HollisterStier LLC
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 103876
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 65044-0778_3c14e8ca-64c9-463f-963d-5a2e31d01ad3SPL ID 3c14e8ca-64c9-463f-963d-5a2e31d01ad3
Pharmacologic class: Non-Standardized Pollen Allergenic Extract; 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

N465044077801 followed by a unit qualifier and the quantity

Package 65044-0778-01. 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.

Other NDCs under BLA 103876

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

FDA NDC Directory listings under BLA 103876
Product	Strength	Form · route	Labeler	Product NDC
Standardized Grass Pollen, Redtop	Agrostis gigantea pollen 10000 [BAU]/mL	Injection, SolutionPercutaneous, Subcutaneous	Jubilant HollisterStier LLC	65044-0777