NDC 49288-0583

Leaf Tobacco

Leaf Tobacco

Leaf Tobacco 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 Tobacco Leaf.

Product ID49288-0583_3af4be6b-c022-4834-9006-f6cc8d8041da
NDC49288-0583
Product TypeHuman Prescription Drug
Proprietary NameLeaf Tobacco
Generic NameLeaf Tobacco
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-23
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameTOBACCO LEAF
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0583-1

2 mL in 1 VIAL, MULTI-DOSE (49288-0583-1)
Marketing Start Date1974-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0583-5 [49288058305]

Leaf Tobacco INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0583-4 [49288058304]

Leaf Tobacco INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0583-3 [49288058303]

Leaf Tobacco INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0583-1 [49288058301]

Leaf Tobacco INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0583-2 [49288058302]

Leaf Tobacco INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
TOBACCO LEAF.02 g/mL

OpenFDA Data

SPL SET ID:d71013ab-718c-4cb0-ae1a-31fdd6db8851
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 967973
  • 889598
  • 966928
  • 968497
  • 1098356
  • 904965
  • 852065
  • 1014199
  • 852547
  • Pharmacological Class

    • Non-Standardized Plant Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Allergens [CS]
    • Plant Proteins [CS]

    NDC Crossover Matching brand name "Leaf Tobacco" or generic name "Leaf Tobacco"

    NDCBrand NameGeneric Name
    49288-0581Leaf TobaccoLeaf Tobacco
    49288-0582Leaf TobaccoLeaf Tobacco
    49288-0583Leaf TobaccoLeaf Tobacco

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