Iva Annua Var Annua Pollen Injection, Solution
NDC 0268-1263

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0268-1263?
  4. Iva Annua Var Annua Pollen Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Iva Annua Var Annua Pollen (marshelder rough) is a BLA-approved product labeled by Alk-abello, Inc.. This medication is typically used as a allergens [cs]. It is supplied as a injection, solution for subcutaneous administration. This product entry covers the primary NDC 0268-1263 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0268-1263
Proprietary Name:
Iva Annua Var Annua Pollen
Non-Proprietary Name: [1]
Marshelder Rough
Substance Name: [2]
Iva Annua Pollen
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]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Alk-abello, Inc.
Labeler Code:
0268
Product Label ID:
1e72cad7-cd64-4c32-bf05-76a32b99e874
FDA Application Number: [6]
BLA103753
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
01-01-1965
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0268-1263?

The NDC code 0268-1263 is assigned by the FDA to the product Iva Annua Var Annua Pollen. It is commonly known by its generic name, marshelder rough. This pharmaceutical product is labeled by Alk-abello, Inc. and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0268-1263-10, 0268-1263-50. 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?

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided.Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.

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.

Which are the associated UNII Codes?

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

  • EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4)
  • EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (Active Moiety)
  • CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9)
  • CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (Active Moiety)
  • MUS MUSCULUS SKIN (UNII: 390AN9GB09)
  • MUS MUSCULUS SKIN (UNII: 390AN9GB09) (Active Moiety)
  • IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV)
  • IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (Active Moiety)
  • RABBIT (UNII: O5V0F26RUW)
  • RABBIT (UNII: O5V0F26RUW) (Active Moiety)
  • PERIPLANETA AMERICANA (UNII: 2RQ1L9N089)
  • PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (Active Moiety)
  • BLATTELLA GERMANICA (UNII: G9O67I0A8Q)
  • BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (Active Moiety)
  • SAROCLADIUM STRICTUM (UNII: 3F36V0451W)
  • SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (Active Moiety)
  • ALTERNARIA ALTERNATA (UNII: 52B29REC7H)
  • ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (Active Moiety)
  • ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)
  • ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (Active Moiety)
  • ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6)
  • ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (Active Moiety)
  • AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK)
  • AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (Active Moiety)
  • BOTRYTIS CINEREA (UNII: TBW53313S7)
  • BOTRYTIS CINEREA (UNII: TBW53313S7) (Active Moiety)
  • CANDIDA ALBICANS (UNII: 4D7G21HDBC)
  • CANDIDA ALBICANS (UNII: 4D7G21HDBC) (Active Moiety)
  • CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A)
  • CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (Active Moiety)
  • CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO)
  • CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (Active Moiety)
  • CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R)
  • CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (Active Moiety)
  • COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W)
  • COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (Active Moiety)
  • EPICOCCUM NIGRUM (UNII: 87U156LEN7)
  • EPICOCCUM NIGRUM (UNII: 87U156LEN7) (Active Moiety)
  • FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ)
  • FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (Active Moiety)
  • HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815)
  • HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (Active Moiety)
  • MUCOR PLUMBEUS (UNII: D7401PWY6E)
  • MUCOR PLUMBEUS (UNII: D7401PWY6E) (Active Moiety)
  • NEUROSPORA INTERMEDIA (UNII: 2072U60DUI)
  • NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (Active Moiety)
  • PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG)
  • PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (Active Moiety)
  • PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M)
  • PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (Active Moiety)
  • RHIZOPUS ARRHIZUS (UNII: 8476849N1Y)
  • RHIZOPUS ARRHIZUS (UNII: 8476849N1Y) (Active Moiety)
  • RHODOTORULA RUBRA (UNII: 15W81V867R)
  • RHODOTORULA RUBRA (UNII: 15W81V867R) (Active Moiety)
  • USTILAGO MAYDIS (UNII: 4K7Z7K7SWG)
  • USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (Active Moiety)
  • USTILAGO TRITICI (UNII: BV82OL2IZ8)
  • USTILAGO TRITICI (UNII: BV82OL2IZ8) (Active Moiety)
  • STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M)
  • STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (Active Moiety)
  • TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV)
  • TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (Active Moiety)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (Active Moiety)
  • ACACIA (UNII: 5C5403N26O)
  • ACACIA (UNII: 5C5403N26O) (Active Moiety)
  • AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3)
  • AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (Active Moiety)
  • ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5)
  • ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (Active Moiety)
  • MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY)
  • MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (Active Moiety)
  • FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD)
  • FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (Active Moiety)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
  • POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA)
  • POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (Active Moiety)
  • PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK)
  • PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (Active Moiety)
  • MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89)
  • MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (Active Moiety)
  • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4)
  • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (Active Moiety)
  • BETULA LENTA POLLEN (UNII: JQ5HI5004M)
  • BETULA LENTA POLLEN (UNII: JQ5HI5004M) (Active Moiety)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P) (Active Moiety)
  • POA ANNUA POLLEN (UNII: 7U437HHU5C)
  • POA ANNUA POLLEN (UNII: 7U437HHU5C) (Active Moiety)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
  • BROMUS INERMIS POLLEN (UNII: 766QT72BK6)
  • BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (Active Moiety)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (Active Moiety)
  • JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y)
  • JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (Active Moiety)
  • JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G)
  • JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (Active Moiety)
  • XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI)
  • XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (Active Moiety)
  • ZEA MAYS POLLEN (UNII: 74PD8J616H)
  • ZEA MAYS POLLEN (UNII: 74PD8J616H) (Active Moiety)
  • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP)
  • POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (Active Moiety)
  • POPULUS FREMONTII POLLEN (UNII: 426RHB4302)
  • POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (Active Moiety)
  • POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441)
  • POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (Active Moiety)
  • CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF)
  • CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (Active Moiety)
  • TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R)
  • TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (Active Moiety)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (Active Moiety)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (Active Moiety)
  • ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I)
  • ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (Active Moiety)
  • ULMUS PUMILA POLLEN (UNII: 030R993R8E)
  • ULMUS PUMILA POLLEN (UNII: 030R993R8E) (Active Moiety)
  • EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9)
  • EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (Active Moiety)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (Active Moiety)
  • CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X)
  • CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (Active Moiety)
  • CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV)
  • CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (Active Moiety)
  • SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP)
  • SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (Active Moiety)
  • JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L)
  • JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (Active Moiety)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (Active Moiety)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
  • ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F)
  • ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (Active Moiety)
  • ACER RUBRUM POLLEN (UNII: 700NK45C76)
  • ACER RUBRUM POLLEN (UNII: 700NK45C76) (Active Moiety)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (Active Moiety)
  • IVA ANNUA POLLEN (UNII: Y2U5S5PF22)
  • IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (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: 1000163 - Alternaria alternata allergenic extract 20000 UNT/ML Injectable Solution
  • RxCUI: 1000163 - Alternaria alternata allergenic extract 20,000 UNT/ML Injectable Solution
  • RxCUI: 1000163 - Alternaria tenuis allergenic extract 20,000 UNT/ML Injectable Solution
  • RxCUI: 1006305 - Aspergillus niger var. niger allergenic extract 40000 UNT/ML Injectable Solution
  • RxCUI: 1006305 - Aspergillus niger var. niger allergenic 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".