NDC 36987-2552

White Birch

White Birch

White Birch 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 Betula Populifolia Pollen.

Product ID36987-2552_e928d8e4-c564-4a56-b4b3-bd495ef410b6
NDC36987-2552
Product TypeHuman Prescription Drug
Proprietary NameWhite Birch
Generic NameWhite Birch
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameBETULA POPULIFOLIA 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 36987-2552-4

50 mL in 1 VIAL, MULTI-DOSE (36987-2552-4)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2552-1 [36987255201]

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

NDC 36987-2552-3 [36987255203]

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

NDC 36987-2552-4 [36987255204]

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

NDC 36987-2552-2 [36987255202]

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

Drug Details

Active Ingredients

IngredientStrength
BETULA POPULIFOLIA POLLEN20000 [PNU]/mL

OpenFDA Data

SPL SET ID:6f5116d1-f99d-47ef-be88-dca38bbe97f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014335
  • 1044512
  • 889558
  • 1014689
  • 1043789
  • 900896
  • 1014684
  • 895362
  • 1044339
  • 1013902
  • 1013927
  • 895685
  • 1014357
  • 900940
  • 1044387
  • 898422
  • 899570
  • 883499
  • 1014718
  • 900074
  • 1013887
  • 1014311
  • 1044400
  • 1013880
  • 1013873
  • 1013869
  • 900030
  • 889630
  • 899602
  • 895449
  • 1044490
  • 899686
  • 1013951
  • 1044355
  • 1044347
  • 899968
  • 1013959
  • 1044213
  • 1044486
  • 1043795
  • 899960
  • 900957
  • 1044357
  • 895378
  • 1014699
  • 1044316
  • 1300000
  • 1014324
  • 1014771
  • 1014222
  • 1006476
  • 1013910
  • 895694
  • 1044300
  • 1043685
  • 900040
  • 899561
  • 899634
  • 899588
  • 1014268
  • 900088
  • 1232595
  • 1044224
  • 899779
  • 900720
  • 1044320
  • 895602
  • 1232570
  • 895708
  • 1044230
  • 1115278
  • 889642
  • 900740
  • 895474
  • 1044519
  • 1013942
  • 899678
  • 1044327
  • 1013968
  • 900056
  • 900120
  • 899698
  • 901031
  • 899984
  • 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 "White Birch" or generic name "White Birch"

    NDCBrand NameGeneric Name
    36987-2549White BirchWhite Birch
    36987-2550White BirchWhite Birch
    36987-2551White BirchWhite Birch
    36987-2552White BirchWhite Birch
    36987-2553White BirchWhite Birch
    36987-2554White BirchWhite Birch
    36987-2555White BirchWhite Birch
    36987-2556White BirchWhite Birch
    49288-0080White BirchWhite Birch
    0268-6610BETULA LENTA POLLENWhite Birch
    0268-6688BETULA LENTA POLLENWhite Birch

    Trademark Results [White Birch]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WHITE BIRCH
    WHITE BIRCH
    87850552 not registered Dead/Abandoned
    GREENPY, INC.
    2018-03-26
    WHITE BIRCH
    WHITE BIRCH
    87816241 5667509 Live/Registered
    Total Clean, LLC
    2018-03-01
    WHITE BIRCH
    WHITE BIRCH
    87816216 5667508 Live/Registered
    Total Clean, LLC
    2018-03-01
    WHITE BIRCH
    WHITE BIRCH
    87300414 5467056 Live/Registered
    Shanghai Duchy Import and Export Co., Ltd
    2017-01-13
    WHITE BIRCH
    WHITE BIRCH
    87165995 not registered Live/Pending
    ELLISON FIRST ASIA, LLC
    2016-09-09
    WHITE BIRCH
    WHITE BIRCH
    86218002 not registered Dead/Abandoned
    White Birch Vineyards, LLC
    2014-03-11
    WHITE BIRCH
    WHITE BIRCH
    85396495 4195835 Live/Registered
    White Birch Productions, LLC
    2011-08-12
    WHITE BIRCH
    WHITE BIRCH
    79386092 not registered Live/Pending
    KPO MARKETING COMPANY LIMITED
    2023-11-21
    WHITE BIRCH
    WHITE BIRCH
    79074429 4144630 Live/Registered
    KPO MARKETING COMPANY LIMITED
    2009-07-13
    WHITE BIRCH
    WHITE BIRCH
    79036518 not registered Dead/Abandoned
    KPO MARKETING COMPANY LIMITED
    2007-02-27
    WHITE BIRCH
    WHITE BIRCH
    78929932 3659495 Live/Registered
    KPO MARKETING COMPANY LIMITED
    2006-07-14
    WHITE BIRCH
    WHITE BIRCH
    78682909 not registered Dead/Abandoned
    White Birch Paper Holding Company
    2005-08-01

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