NDC 36987-2440

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 ID36987-2440_19424a5a-5a7a-4ee6-bc1e-f6fce765f047
NDC36987-2440
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 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],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 36987-2440-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2440-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2440-1 [36987244001]

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

NDC 36987-2440-4 [36987244004]

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

NDC 36987-2440-2 [36987244002]

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

NDC 36987-2440-3 [36987244003]

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 POLLEN20000 [PNU]/mL

OpenFDA Data

SPL SET ID:7da91ce2-a4c4-4f09-be92-ff74c311b1d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889666
  • 897359
  • 899541
  • 889565
  • 900012
  • 897351
  • 898409
  • 1014347
  • 899976
  • 900161
  • 898136
  • 1044242
  • 1013966
  • 889530
  • 1044526
  • 1044504
  • 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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