NDC 36987-3148

Groundsel

Groundsel

Groundsel is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Baccharis Halimifolia Pollen.

Product ID36987-3148_b936d0e6-7b7a-465f-a970-9c600e585844
NDC36987-3148
Product TypeHuman Prescription Drug
Proprietary NameGroundsel
Generic NameGroundsel
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameBACCHARIS HALIMIFOLIA POLLEN
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-3148-1

5 mL in 1 VIAL, MULTI-DOSE (36987-3148-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-3148-3 [36987314803]

Groundsel INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3148-2 [36987314802]

Groundsel INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3148-1 [36987314801]

Groundsel INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-3148-4 [36987314804]

Groundsel INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
BACCHARIS HALIMIFOLIA POLLEN.1 g/mL

OpenFDA Data

SPL SET ID:895c9692-bebf-4c26-acf2-8a4036370728
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014002
  • 897961
  • 897309
  • 896160
  • 1013982
  • 1006361
  • 896283
  • 897337
  • 896203
  • 1006482
  • 895616
  • 897370
  • 896120
  • 897508
  • 898329
  • 897396
  • 896084
  • 897378
  • 897991
  • 897953
  • 897970
  • 995611
  • 901490
  • 896179
  • 896152
  • 897321
  • 896292
  • 1006353
  • 895721
  • 895606
  • 895729
  • 896074
  • 896251
  • 897945
  • 896275
  • 896259
  • 901035
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Groundsel" or generic name "Groundsel"

    NDCBrand NameGeneric Name
    36987-3141GroundselGroundsel
    36987-3142GroundselGroundsel
    36987-3143GroundselGroundsel
    36987-3144GroundselGroundsel
    36987-3145GroundselGroundsel
    36987-3146GroundselGroundsel
    36987-3147GroundselGroundsel
    36987-3148GroundselGroundsel

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