NDC 36987-3141

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 ID36987-3141_45a21265-75ff-4634-a154-faff541e45d6
NDC36987-3141
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 Strength10000 [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 36987-3141-4

50 mL in 1 VIAL, MULTI-DOSE (36987-3141-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-3141-4 [36987314104]

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

NDC 36987-3141-2 [36987314102]

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

NDC 36987-3141-1 [36987314101]

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

NDC 36987-3141-3 [36987314103]

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 POLLEN10000 [PNU]/mL

OpenFDA Data

SPL SET ID:98bdde2e-6f04-4ff4-a6e3-1348d31c1bb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897963
  • 897311
  • 897398
  • 896167
  • 1013980
  • 1006363
  • 896286
  • 1006484
  • 895610
  • 895675
  • 896205
  • 897372
  • 896123
  • 1013984
  • 896182
  • 896261
  • 896086
  • 897993
  • 897955
  • 897973
  • 901473
  • 897323
  • 1006355
  • 896296
  • 896154
  • 895723
  • 308004
  • 1006490
  • 895909
  • 896076
  • 897947
  • 896277
  • 896253
  • 897510
  • 897380
  • 898335
  • 897339
  • 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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