NDC 36987-2438

Smooth Brome

Smooth Brome

Smooth Brome 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 Bromus Inermis Pollen.

Product ID36987-2438_5efa434d-c520-47eb-8524-f97ccebad6fc
NDC36987-2438
Product TypeHuman Prescription Drug
Proprietary NameSmooth Brome
Generic NameSmooth Brome
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameBROMUS INERMIS 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],Non-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 36987-2438-4

50 mL in 1 VIAL, MULTI-DOSE (36987-2438-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2438-1 [36987243801]

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

NDC 36987-2438-4 [36987243804]

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

NDC 36987-2438-3 [36987243803]

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

NDC 36987-2438-2 [36987243802]

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

Drug Details

Active Ingredients

IngredientStrength
BROMUS INERMIS POLLEN10000 [PNU]/mL

OpenFDA Data

SPL SET ID:f826609e-90d3-43e4-a125-ce397fce965f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044502
  • 897349
  • 889567
  • 1044523
  • 897357
  • 889668
  • 900010
  • 1014345
  • 899974
  • 1044252
  • 1000015
  • 900155
  • 898134
  • 897331
  • 1044494
  • 889532
  • Pharmacological Class

    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • 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 "Smooth Brome" or generic name "Smooth Brome"

    NDCBrand NameGeneric Name
    22840-1205Smooth BromeBromus inermis
    22840-1206Smooth BromeBromus inermis
    22840-1207Smooth BromeBromus inermis
    22840-1239Smooth BromeBromus inermis
    22840-1240Smooth BromeBromus inermis
    22840-1241Smooth BromeBromus inermis
    22840-5201Smooth BromeBromus inermis
    36987-2437Smooth BromeSmooth Brome
    36987-2438Smooth BromeSmooth Brome
    36987-2439Smooth BromeSmooth Brome
    36987-2440Smooth BromeSmooth Brome
    36987-2441Smooth BromeSmooth Brome
    36987-2442Smooth BromeSmooth Brome
    36987-2443Smooth BromeSmooth Brome
    36987-2444Smooth BromeSmooth Brome

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