Food - Animal Products And Poultry Products, Egg, White Gallus Sp. Injection, Solution
NDC 65044-3248

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 65044-3248?
  4. Food - Animal Products And Poultry Products, Egg, White Gallus Sp. Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Food - Animal Products And Poultry Products, Egg, White Gallus Sp. (egg, white gallus sp.) is a BLA-approved product labeled by Jubilant Hollisterstier Llc. This medication is typically used as a allergens [cs]. It is supplied as a injection, solution for percutaneous; subcutaneous administration. This product entry covers the primary NDC 65044-3248 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65044-3248
Proprietary Name:
Food - Animal Products And Poultry Products, Egg, White Gallus Sp.
Non-Proprietary Name: [1]
Egg, White Gallus Sp.
Substance Name: [2]
Egg White
NDC Directory Status:
Non-standardized Allergenic
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
  • Percutaneous - Administration through the skin.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Jubilant Hollisterstier Llc
Labeler Code:
65044
Product Label ID:
97e5c6c0-7101-49b7-8ac4-9dfc60f60cc5
FDA Application Number: [6]
BLA103888
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
04-19-1941
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 65044-3248?

The NDC code 65044-3248 is assigned by the FDA to the product Food - Animal Products And Poultry Products, Egg, White Gallus Sp.. It is commonly known by its generic name, egg, white gallus sp.. This pharmaceutical product is labeled by Jubilant Hollisterstier Llc and is currently categorized as listed product. The medication is a injection, solution administered via percutaneous; subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 65044-3248-2. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

20,21,22,23Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen. Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to dog dander in kennel owners and employees, dog breeders, research workers, veterinarians, etc. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur with the highly reactive allergen.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • EGG WHITE .05 g/mL - The white of an egg, especially a chicken's egg, used in cooking. It contains albumin. (Random House Unabridged Dictionary, 2d ed)

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • EQUUS CABALLUS HAIR (UNII: 4F35XG0149)
  • EQUUS CABALLUS HAIR (UNII: 4F35XG0149) (Active Moiety)
  • EQUUS CABALLUS DANDER (UNII: J81SZ18495)
  • EQUUS CABALLUS DANDER (UNII: J81SZ18495) (Active Moiety)
  • BOS TAURUS HAIR (UNII: TOQ97Z8644)
  • BOS TAURUS HAIR (UNII: TOQ97Z8644) (Active Moiety)
  • BOS TAURUS DANDER (UNII: C8VYS726O8)
  • BOS TAURUS DANDER (UNII: C8VYS726O8) (Active Moiety)
  • CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR)
  • CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (Active Moiety)
  • CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4)
  • CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (Active Moiety)
  • GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV)
  • GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (Active Moiety)
  • ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796)
  • ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (Active Moiety)
  • ANSER ANSER FEATHER (UNII: 15XI414745)
  • ANSER ANSER FEATHER (UNII: 15XI414745) (Active Moiety)
  • CAVIA PORCELLUS HAIR (UNII: KBA5Y6X57N)
  • CAVIA PORCELLUS HAIR (UNII: KBA5Y6X57N) (Active Moiety)
  • CAVIA PORCELLUS DANDER (UNII: 84Q71TU5SU)
  • CAVIA PORCELLUS DANDER (UNII: 84Q71TU5SU) (Active Moiety)
  • BEEF (UNII: 4PIB2155QP)
  • BEEF (UNII: 4PIB2155QP) (Active Moiety)
  • POULTRY, UNSPECIFIED (UNII: L7WXO2P5HM)
  • POULTRY, UNSPECIFIED (UNII: L7WXO2P5HM) (Active Moiety)
  • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627)
  • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (Active Moiety)
  • SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB)
  • SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (Active Moiety)
  • PARKINSONIA FLORIDA POLLEN (UNII: 57586C96ZL)
  • PARKINSONIA FLORIDA POLLEN (UNII: 57586C96ZL) (Active Moiety)
  • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y)
  • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (Active Moiety)
  • SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1)
  • SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (Active Moiety)
  • PINUS CONTORTA POLLEN (UNII: FB7IP650ET)
  • PINUS CONTORTA POLLEN (UNII: FB7IP650ET) (Active Moiety)
  • PINUS PONDEROSA POLLEN (UNII: 042SUA2DS9)
  • PINUS PONDEROSA POLLEN (UNII: 042SUA2DS9) (Active Moiety)
  • LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E)
  • LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (Active Moiety)
  • ELAEAGNUS ANGUSTIFOLIA POLLEN (UNII: 68P4F4M6VD)
  • ELAEAGNUS ANGUSTIFOLIA POLLEN (UNII: 68P4F4M6VD) (Active Moiety)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P) (Active Moiety)
  • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR)
  • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (Active Moiety)
  • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP)
  • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (Active Moiety)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (Active Moiety)
  • CARYA OVATA POLLEN (UNII: 54UN9R2798)
  • CARYA OVATA POLLEN (UNII: 54UN9R2798) (Active Moiety)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
  • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C)
  • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (Active Moiety)
  • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN)
  • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (Active Moiety)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
  • ACER RUBRUM POLLEN (UNII: 700NK45C76)
  • ACER RUBRUM POLLEN (UNII: 700NK45C76) (Active Moiety)
  • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO)
  • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (Active Moiety)
  • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK)
  • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (Active Moiety)
  • BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY)
  • BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (Active Moiety)
  • BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y)
  • BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (Active Moiety)
  • AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3)
  • AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (Active Moiety)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (Active Moiety)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (Active Moiety)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (Active Moiety)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
  • URTICA DIOICA POLLEN (UNII: DNB59M1NVU)
  • URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (Active Moiety)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (Active Moiety)
  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI)
  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (Active Moiety)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (Active Moiety)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (Active Moiety)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (Active Moiety)
  • ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D)
  • ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (Active Moiety)
  • ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83)
  • ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (Active Moiety)
  • CYTISUS SCOPARIUS FLOWERING TOP (UNII: XZC6H8R666)
  • CYTISUS SCOPARIUS FLOWERING TOP (UNII: XZC6H8R666) (Active Moiety)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (Active Moiety)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)
  • AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3)
  • AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (Active Moiety)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (Active Moiety)
  • IVA AXILLARIS POLLEN (UNII: 13KFG30UBR)
  • IVA AXILLARIS POLLEN (UNII: 13KFG30UBR) (Active Moiety)
  • IVA ANNUA POLLEN (UNII: Y2U5S5PF22)
  • IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (Active Moiety)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (Active Moiety)
  • EGG WHITE (UNII: 3E0I92Z2GR)
  • EGG WHITE (UNII: 3E0I92Z2GR) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1006482 - nettle pollen extract 100 MG/ML Injectable Solution
  • RxCUI: 1006482 - Urtica dioica pollen extract 0.1 GM/ML Injectable Solution
  • RxCUI: 1006482 - Urtica dioica pollen extract 100 MG/ML Injectable Solution
  • RxCUI: 1013991 - rough cocklebur pollen extract 40000 UNT/ML Injectable Solution
  • RxCUI: 1013991 - Xanthium strumarium pollen extract 40,000 UNT/ML Injectable Solution

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".