NDC codes

FDA NDC Directory
Product NDC (as listed)65044-0842Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-0842Add 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
65044-0842-1650440842015 mL in 1 VIAL (65044-0842-1)Marketed from Jan 15, 1998
65044-0842-26504408420210 mL in 1 VIAL (65044-0842-2)Marketed from Jan 15, 1998
65044-0842-36504408420330 mL in 1 VIAL (65044-0842-3)Marketed from Jan 15, 1998
65044-0842-46504408420450 mL in 1 VIAL (65044-0842-4)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

Generic name (nonproprietary)
standardized grass pollen, grass mix 4
Active ingredients
Poa pratensis pollen — 25000 [BAU]/mLDactylis glomerata pollen — 25000 [BAU]/mLAgrostis gigantea pollen — 25000 [BAU]/mLPhleum pratense pollen — 25000 [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 103873
Marketing start
Listing expires
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 65044-0842_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

N465044084201 followed by a unit qualifier and the quantity

Package 65044-0842-01. 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 65044-0842

What is NDC 65044-0842?
65044-0842 is the product NDC for Standardized Grass Pollen, Grass Mix 4, Poa pratensis pollen 25000 [BAU]/mL + 3 more ingredients 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, Grass Mix 4.
What is the active ingredient?
Poa pratensis pollen, Dactylis glomerata pollen, Agrostis gigantea pollen, Phleum 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, Grass Mix 4?
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 103873

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

FDA NDC Directory listings under BLA 103873
ProductStrengthForm · routeLabelerProduct NDC
Standardized Grass Pollen, Bluegrass, Kentucky JunePoa pratensis pollen 10000 [BAU]/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-0545
Standardized Grass Pollen, Bluegrass, Kentucky JunePoa pratensis pollen 100000 [BAU]/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-0546

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in