NDC codes

FDA NDC Directory
Product NDC (as listed)65044-2297Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-2297Add 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
65044-2297-165044229701650442297015 mL in 1 VIAL (65044-2297-1)Marketed from Oct 18, 1977
65044-2297-2650442297026504422970210 mL in 1 VIAL (65044-2297-2)Marketed from Oct 18, 1977
65044-2297-4650442297046504422970450 mL in 1 VIAL (65044-2297-4)Marketed from Oct 18, 1977

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)
short ragweed, ambrosia artemisiifolia
Active ingredients
Ambrosia artemisiifolia pollen — .05 g/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 103880
Marketing start
Listing expires
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 65044-2297_5e6a7a02-f790-4786-96ea-11aa48dfa5d9SPL ID 5e6a7a02-f790-4786-96ea-11aa48dfa5d9
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

N465044229701 followed by a unit qualifier and the quantity

Package 65044-2297-01. 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 65044-2297

What is NDC 65044-2297?
65044-2297 is the product NDC for Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia, Ambrosia artemisiifolia pollen .05 g/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia (Short Ragweed, Ambrosia artemisiifolia).
What is the active ingredient?
Ambrosia artemisiifolia 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 Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia?
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 103880

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

FDA NDC Directory listings under BLA 103880
ProductStrengthForm · routeLabelerProduct NDC
Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosiaragweed, mixed ambrosiaAmbrosia trifida pollen .05 g/mL; Ambrosia artemisiifolia pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2315

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