NDC 36987-2545

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 ID36987-2545_2a72f629-5585-48e0-bd3f-7804035e57fb
NDC36987-2545
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 Strength40000 [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 36987-2545-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2545-2)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2545-1 [36987254501]

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

NDC 36987-2545-3 [36987254503]

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

NDC 36987-2545-4 [36987254504]

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

NDC 36987-2545-2 [36987254502]

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 POLLEN40000 [PNU]/mL

OpenFDA Data

SPL SET ID:9e44c782-6ad1-4e86-b333-e9358cbc5867
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014726
  • 1045589
  • 1014337
  • 900006
  • 1232601
  • 1014720
  • 1300002
  • 900905
  • 1115281
  • 1013904
  • 1232614
  • 889556
  • 1014359
  • 1014765
  • 1014313
  • 900859
  • 1232580
  • 899572
  • 1013889
  • 899769
  • 900058
  • 900077
  • 1232597
  • 900942
  • 899590
  • 1014703
  • 1045597
  • 1193018
  • 889639
  • 1013961
  • 899604
  • 895710
  • 900036
  • 1046211
  • 1013871
  • 1013953
  • 900960
  • 899680
  • 900091
  • 895687
  • 1046217
  • 1232576
  • 899962
  • 899781
  • 1045602
  • 1232599
  • 1014686
  • 1014326
  • 1006478
  • 1193022
  • 1045583
  • 1013912
  • 895364
  • 899563
  • 899636
  • 1014225
  • 900042
  • 1014773
  • 1014724
  • 1045587
  • 1193026
  • 1014730
  • 900722
  • 1014307
  • 1115829
  • 889628
  • 1046209
  • 895457
  • 1045632
  • 895604
  • 895380
  • 1013875
  • 895700
  • 900742
  • 992836
  • 899970
  • 1045595
  • 1115835
  • 895396
  • 1045591
  • 899692
  • 900122
  • 901033
  • 895476
  • 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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