49288-0226 NDC - SWEET GUM

Drug Information

Product NDC: 49288-0226

Proprietary Name: Sweet Gum

Non Proprietary Name: Sweet Gum

Active Ingredient(s):

Administration Route(s): INTRADERMAL; SUBCUTANEOUS


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

Labeler Information

Labeler Name: Antigen Laboratories, Inc.
FDA Application Number: BLA102223
Marketing Category: BLA
Start Marketing Date:3/23/1974

Package Information

No. Package Code Package Description Billing Unit
149288-0226-12 mL in 1 VIAL, MULTI-DOSE (49288-0226-1)
249288-0226-25 mL in 1 VIAL, MULTI-DOSE (49288-0226-2)
349288-0226-310 mL in 1 VIAL, MULTI-DOSE (49288-0226-3)
449288-0226-430 mL in 1 VIAL, MULTI-DOSE (49288-0226-4)
549288-0226-550 mL in 1 VIAL, MULTI-DOSE (49288-0226-5)

NDC Record

Field Name Field Value Definition
PRODUCT NDC49288-0226The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates 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 NAMESweet GumThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESweet GumThe 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 NAMEINTRADERMAL; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/23/1974This 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 NUMBERBLA102223This 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 NAMEAntigen Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELIQUIDAMBAR STYRACIFLUA POLLENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS] 

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This page was last updated on: 7/15/2019