NDC codes

FDA NDC Directory
Product NDC (as listed)65044-3390Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-3390Add 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
65044-3390-1650443390015 mL in 1 VIAL (65044-3390-1)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)
milk, whole cow
Active ingredients
Cow milk — .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)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Milk Proteins (Chemical structure)
Identifiers
Product ID 65044-3390_d6fcbcef-b35a-48a4-968c-6da0f3817dbeSPL ID d6fcbcef-b35a-48a4-968c-6da0f3817dbe
Pharmacologic class
Non-Standardized Food 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

N465044339001 followed by a unit qualifier and the quantity

Package 65044-3390-01. 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 65044-3390

What is NDC 65044-3390?
65044-3390 is the product NDC for Food - Dairy Products, Milk, Whole Cow, Cow milk .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?
Food - Dairy Products, Milk, Whole Cow (Milk, Whole Cow).
What is the active ingredient?
Cow milk.
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 Food - Dairy Products, Milk, Whole Cow?
1 other product NDC are listed under this name. See all Food - Dairy Products, Milk, Whole Cow 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 Food - Dairy Products, Milk, Whole Cow NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Food - Dairy Products, Milk, Whole Cowmilk, whole cowCow milk .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-338965044-3389-02

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 - Grasses, Southern Grass MixPoa pratensis pollen 10000 [BAU]/mL + 6 more ingredientsInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-0856
Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiaeyeast, brewer saccharomyces cerevisiaeYeast .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3716
Pollens - Grasses, Southern Grass MixPoa pratensis pollen 100000 [BAU]/mL + 6 more ingredientsInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-0855
Food - Plant Source, Yeast, Baker Saccharomyces cerevisiaeyeast, baker saccharomyces cerevisiaeYeast .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3713
Food - Plant Source, Yeast, Baker Saccharomyces cerevisiaeyeast, baker saccharomyces cerevisiaeYeast .1 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-3714
Food - Animal Products and Poultry Products, Chicken Meat Gallus sp.chicken meat gallus sp.Poultry, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3173
Food - Plant Source, Carrot Daucus carotacarrot daucus carotaCarrot .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3125
Food - Plant Source, Cashew Nut Anacardium occidentaliecashew nut anacardium occidentalieCashew .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3134
Food - Plant Source, Celery Apium graveolenscelery apium graveolensCelery .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3140
Food - Animal Products and Poultry Products, Chicken Meat Gallus sp.chicken meat gallus sp.Poultry, Unspecified .1 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-3174
Food - Fish and Shellfish, ClamclamQuahog, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3191
Food - Fish and Shellfish, Codfish Gadus callariascodfish gadus callariasCod, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3203
Food - Animal Products and Poultry Products, Egg, White Gallus sp.egg, white gallus sp.Egg white .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3248
Food - Plant Source, Corn Zea mayscorn zea maysCorn .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3212
Food - Fish and Shellfish, Crab Xiphosurus sowerbyicrab xiphosurus sowerbyiCrab leg, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3215
Food - Plant Source, Hazelnut Filbert Corylus spp.hazelnut filbert corylus spp.Hazelnut, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3305
Food - Animal Products and Poultry Products, Egg, White Gallus sp.egg, white gallus sp.Egg white .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-3249
Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp.egg, yolk gallus sp.Egg yolk .05 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3254
Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp.egg, yolk gallus sp.Egg yolk .05 g/mLInjection, SolutionPercutaneousJubilant HollisterStier LLC65044-3255
Food - Fish and Shellfish, Lobster Homarus americanuslobster homarus americanusLobster, Unspecified .1 g/mLInjection, SolutionPercutaneous, SubcutaneousJubilant HollisterStier LLC65044-3362

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