NDC 49288-9935

Sterile Diluent for Allergenic Extract

Glycerine

Sterile Diluent for Allergenic Extract is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Glycerin.

Product ID49288-9935_60ce9c8c-5855-42da-91ee-8bfe8edf51ab
NDC49288-9935
Product TypeHuman Prescription Drug
Proprietary NameSterile Diluent for Allergenic Extract
Generic NameGlycerine
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-23
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameGLYCERIN
Active Ingredient Strength1 mL/mL
Pharm ClassesNon-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Glycerol [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-9935-5

24 mL in 1 VIAL (49288-9935-5)
Marketing Start Date1974-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-9935-1 [49288993501]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-9935-5 [49288993505]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-9935-3 [49288993503]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-9935-2 [49288993502]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-9935-4 [49288993504]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-9935-6 [49288993506]

Sterile Diluent for Allergenic Extract INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
GLYCERIN.5 mL/mL

OpenFDA Data

SPL SET ID:026d3185-aa37-42f8-95a0-7243e0947b7a
Manufacturer
UNII
Pharm Class PE
  • Increased Oncotic Pressure [PE]
  • Increased Intravascular Volume [PE]
  • PHarm Class EPC
  • Human Serum Albumin [EPC]
  • UPC Code
  • 0349288993216
  • 0349288993414
  • 0349288993513
  • 0349288993315
  • NUI Code
  • N0000010288
  • N0000009361
  • N0000169504
  • N0000009457
  • N0000184174
  • Pharmacological Class

    • Non-Standardized Chemical Allergen [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Allergens [CS]
    • Glycerol [CS]

    NDC Crossover Matching brand name "Sterile Diluent for Allergenic Extract" or generic name "Glycerine"

    NDCBrand NameGeneric Name
    49288-9932Sterile Diluent for Allergenic ExtractGlycerine and Phenol
    49288-9933Sterile Diluent for Allergenic ExtractPhenol
    49288-9934Sterile Diluent for Allergenic ExtractHuman Albumin and Phenol
    49288-9935Sterile Diluent for Allergenic ExtractGlycerine
    49288-9936Sterile Diluent for Allergenic ExtractGlycerine and Phenol
    49953-1894Lemon GlycerinGlycerine
    60913-061Lemon GlycerineGlycerine

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