PRODUCT NDC | 22840-2479 | The 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 NAME | NON-STANDARDIZED ALLERGENIC | 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. |
PROPRIETARY NAME | Arizona Gambel Oak Pollen | 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. |
NON PROPRIETARY NAME | Quercus gambelii | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
DOSAGE FORM NAME | SOLUTION | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
ROUTE NAME | INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS | The translation of the route code submitted by the firm, indicating route of administration. |
START MARKETING DATE | 9/15/1981 | The translation of the route code submitted by the firm, indicating route of administration. |
MARKETING CATEGORY NAME | BLA | 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. |
APPLICATION NUMBER | BLA101833 | 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. |
LABELER NAME | Greer Laboratories, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
SUBSTANCE NAME | QUERCUS GAMBELII POLLEN | Name of Company corresponding to the labeler code segment of the Product NDC. |
ACTIVE NUMERATOR STRENGTH | .1 | |
ACTIVE INGRED UNIT | g/mL | |
PHARM CLASSES | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS] | |