NDC 36987-2544

Black Birch

Black Birch

Black 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 Lenta Pollen.

Product ID36987-2544_e928d8e4-c564-4a56-b4b3-bd495ef410b6
NDC36987-2544
Product TypeHuman Prescription Drug
Proprietary NameBlack Birch
Generic NameBlack Birch
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameBETULA LENTA POLLEN
Active Ingredient Strength20000 [PNU]/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2544-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2544-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2544-1 [36987254401]

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

NDC 36987-2544-3 [36987254403]

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

NDC 36987-2544-4 [36987254404]

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

NDC 36987-2544-2 [36987254402]

Black 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 LENTA 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

    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]

    NDC Crossover Matching brand name "Black Birch" or generic name "Black Birch"

    NDCBrand NameGeneric Name
    36987-2541Black BirchBlack Birch
    36987-2542Black BirchBlack Birch
    36987-2543Black BirchBlack Birch
    36987-2544Black BirchBlack Birch
    36987-2545Black BirchBlack Birch
    36987-2546Black BirchBlack Birch
    36987-2547Black BirchBlack Birch
    36987-2548Black BirchBlack Birch
    49288-0626Black BirchBlack Birch
    0268-6608BETULA LENTA POLLENBlack Birch
    0268-6686BETULA LENTA POLLENBlack Birch

    Trademark Results [Black Birch]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BLACK BIRCH
    BLACK BIRCH
    88898688 not registered Live/Pending
    Cintron, Eduardo
    2020-05-03
    BLACK BIRCH
    BLACK BIRCH
    85253972 not registered Dead/Abandoned
    The New Zealand Wine Company Limited
    2011-02-28

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