0268-8002 NDC - 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN)

Drug Information

Product NDC: 0268-8002

Proprietary Name: 4 WEED MIX

Non Proprietary Name: AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN

Active Ingredient(s):
  • .05 g/mL AMARANTHUS RETROFLEXUS POLLEN;
  • .05 g/mL CHENOPODIUM ALBUM POLLEN;
  • .05 g/mL PLANTAGO LANCEOLATA POLLEN;
  • .05 g/mL XANTHIUM STRUMARIUM POLLEN


Administration Route(s): SUBCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Increased IgG Production [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Non-Standardized Pollen Allergenic Extract [EPC];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS];
  • Pollen [CS]

Labeler Information

Labeler Name: ALK-Abello, Inc.
Product Type: NON-STANDARDIZED ALLERGENIC
FDA Application Number: BLA103753
Marketing Category: BLA
Start Marketing Date:2/23/1998

Package Information

No. Package Code Package Description Billing Unit
10268-8002-065.5 mL in 1 VIAL (0268-8002-06)
20268-8002-1010.5 mL in 1 VIAL (0268-8002-10)
30268-8002-5053 mL in 1 VIAL (0268-8002-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0268-8002The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMENON-STANDARDIZED ALLERGENICIndicates 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.
PROPRIETARY NAME4 WEED MIXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN and XANTHIUM STRUMARIUM POLLENThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEPERCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/1965This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA103753This 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.
LABELER NAMEALK-Abello, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA POLLEN; XANTHIUM STRUMARIUM POLLENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.05; .05; .05; .05 
ACTIVE INGRED UNITg/mL; g/mL; g/mL; g/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS] 
PRODUCT NDC0268-8002The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMENON-STANDARDIZED ALLERGENICIndicates 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.
PROPRIETARY NAME4 WEED MIXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLENThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/23/1998This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA103753This 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.
LABELER NAMEALK-Abello, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA POLLEN; XANTHIUM STRUMARIUM POLLENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.05; .05; .05; .05 
ACTIVE INGRED UNITg/mL; g/mL; g/mL; g/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS] 

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This page was last updated on: 2/14/2022