NDC 65044-2359-2 Pollens - Trees, Russian Olive Elaeagnus Angustifolia

Russian Olive Elaeagnus Angustifolia

NDC Package Code 65044-2359-2

The NDC Code 65044-2359-2 is assigned to a package of 10 ml in 1 vial of Pollens - Trees, Russian Olive Elaeagnus Angustifolia, a non-standardized allergenic label labeled by Jubilant Hollisterstier Llc. The product's dosage form is injection, solution and is administered via percutaneous; subcutaneous form.

Field Name Field Value
NDC Code 65044-2359-2
Package Description 10 mL in 1 VIAL
Proprietary Name Pollens - Trees, Russian Olive Elaeagnus Angustifolia What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Russian Olive Elaeagnus Angustifolia What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 65044235902 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
RxNorm Crosswalk1006482, 1013991, 1091110, 1091115, 1115265, 1193014, 1242958, 851877, 851893, 851917, 851929, 851933, 851988, 852001, 852018, 852032, 852049, 852057, 852060, 852077, 852105, 852117, 852139, 852143, 852161, 852165, 852192, 852216, 852220, 852224, 852236, 852240, 852271, 852275, 852323, 852327, 852362, 852366, 852370, 852407, 852422, 852453, 852469, 852572, 852584, 852596, 852612, 852625, 852630, 852656, 852676, 852690, 852745, 852749, 852817, 852847, 854133, 883416, 889556, 889650, 889671, 891657, 891663, 891675, 891681, 891774, 891833, 892335, 892371, 892375, 892487, 892502, 892506, 892510, 892520, 892529, 892542, 892546, 892550, 892564, 892568, 892572, 892578, 892587, 892595, 892602, 892607, 892613, 892619, 892623, 892631, 892635, 892641, 892656, 892664, 892668, 892677, 895368, 895704, 895716, 895720, 896160, 896179, 896275, 896281, 896283, 897361, 897378, 897382, 897384, 897502, 897506, 897982, 897984, 897991, 898002, 898016, 898019, 898024, 898132, 898327, 898329, 898337, 898339, 898422, 899504, 899958, 900095, 901035, 901487, 901489, 901492, 901848, 903916, 905075, 966777, 966784, 966966, 967032, 967053, 967761, 968012, 991857, 991865, 995555, 995557, 995560, 995561, 995604, 995611, 995697, 995702, 995706, 995710, 995714, 995725, 995746, 995750, 995757 and 995771 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Non-standardized Allergenic What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Jubilant Hollisterstier Llc
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
  • ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL
Pharmacological Class(es)
  • Non-Standardized Pollen Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Pollen - [CS]
  • Allergens - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number BLA103888 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 04-19-1941 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 65044 - Jubilant Hollisterstier Llc
    • 65044-2359 - Pollens - Trees, Russian Olive Elaeagnus Angustifolia
      • 65044-2359-2 - 10 mL in 1 VIAL

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Pollens - Trees, Russian Olive Elaeagnus Angustifolia with product NDC 65044-2359.

NDC Package CodePackage Description
65044-2359-330 mL in 1 VIAL
65044-2359-450 mL in 1 VIAL

* Please review the disclaimer below.