NDC 36987-3143

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 ID36987-3143_d152b7aa-b962-4303-9744-c8947edc1d6d
NDC36987-3143
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 Strength20000 [PNU]/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 36987-3143-3

30 mL in 1 VIAL, MULTI-DOSE (36987-3143-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-3143-4 [36987314304]

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

NDC 36987-3143-1 [36987314301]

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

NDC 36987-3143-3 [36987314303]

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

NDC 36987-3143-2 [36987314302]

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 POLLEN20000 [PNU]/mL

OpenFDA Data

SPL SET ID:efc51970-c1a4-45e7-864b-4f0587896459
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 896125
  • 897966
  • 897313
  • 896288
  • 1006365
  • 895677
  • 1006486
  • 895612
  • 895912
  • 896208
  • 897374
  • 896088
  • 896263
  • 1013972
  • 1013970
  • 897400
  • 897995
  • 897975
  • 897957
  • 896171
  • 901475
  • 896298
  • 901493
  • 1006357
  • 896156
  • 897325
  • 896078
  • 895725
  • 1006492
  • 897341
  • 896255
  • 896196
  • 897512
  • 897382
  • 898337
  • 897949
  • 896279
  • 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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