NDC codes

FDA NDC Directory
Product NDC (as listed)65044-2015Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-2015Add 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
65044-2015-165044201501650442015015 mL in 1 VIAL (65044-2015-1)Marketed from Apr 19, 1941

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)
oak, red quercus rubra
Active ingredients
Quercus rubra pollen — .05 g/mL
Dosage form
Injection, Solution
Route
Percutaneous
Labeler
Jubilant HollisterStier LLCNDC labeler code 65044
Product type
Non-standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 103888
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 65044-2015_d6fcbcef-b35a-48a4-968c-6da0f3817dbeSPL ID d6fcbcef-b35a-48a4-968c-6da0f3817dbe
Pharmacologic class
Non-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

N465044201501 followed by a unit qualifier and the quantity

Package 65044-2015-01. 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 65044-2015

What is NDC 65044-2015?
65044-2015 is the product NDC for Pollens - Trees, Oak, Red Quercus rubra, Quercus rubra pollen .05 g/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pollens - Trees, Oak, Red Quercus rubra (Oak, Red Quercus rubra).
What is the active ingredient?
Quercus rubra 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 - Trees, Oak, Red Quercus rubra?
1 other product NDC are listed under this name. See all Pollens - Trees, Oak, Red Quercus rubra 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 Pollens - Trees, Oak, Red Quercus rubra NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pollens - Trees, Oak, Red Quercus rubraoak, red quercus rubraQuercus rubra pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-201465044-2014-0265044-2014-0365044-2014-04

Other NDCs under BLA 103888

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

FDA NDC Directory listings under BLA 103888
ProductStrengthForm · routeLabelerProduct NDC
Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifidaragweed, giant ambrosia trifidaAmbrosia trifida pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2294
Pollens - Trees, Privet Ligustrum vulgareprivet ligustrum vulgareLigustrum vulgare pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2251
Pollens - Trees, Privet Ligustrum vulgareprivet ligustrum vulgareLigustrum vulgare pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2252
Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifidaragweed, giant ambrosia trifidaAmbrosia trifida pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2293
Pollens - Trees, Mulberry Mixmulberry mixMorus alba pollen .1 g/mL; Morus rubra pollen .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-1912
Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioicaUrtica dioica pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-1945
Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioicaUrtica dioica pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-1946
Pollens - Trees, Palo Verde Cercidium floridumpalo verde cercidium floridumParkinsonia florida pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2017
Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioicaUrtica dioica pollen .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-1947
Pollens - Trees, Oak, Red Quercus rubraoak, red quercus rubraQuercus rubra pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2014
Pollens - Trees, Oak Mixoak mixQuercus rubra pollen .1 g/mL + 2 more ingredientsInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2038
Pollens - Trees, Palo Verde Cercidium floridumpalo verde cercidium floridumParkinsonia florida pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2018
Pollens - Trees, Oak Mixoak mixQuercus rubra pollen .05 g/mL + 2 more ingredientsInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2035
Pollens - Trees, Oak Mixoak mixQuercus rubra pollen .05 g/mL + 2 more ingredientsInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2036
Pollens - Grasses, Oats, Common, Cultivated Avena sativaoats, common, cultivated avena sativaAvena sativa pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2042
Pollens - Trees, Oak Mixoak mixQuercus rubra pollen 20000 [PNU]/mL + 2 more ingredientsInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2039
Pollens - Grasses, Oats, Common, Cultivated Avena sativaoats, common, cultivated avena sativaAvena sativa pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2041
Pollens - Weeds and Garden Plants, Dog Fennel, Eastern Eupatorium capillifoliumdog fennel, eastern eupatorium capillifoliumEupatorium capillifolium pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2057
Pollens - Trees, Olive Olea europaeaolive olea europaeaOlea europaea pollen .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-2050
Pollens - Trees, Olive Olea europaeaolive olea europaeaOlea europaea pollen .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-2051

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