NDC 36987-2542

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 ID36987-2542_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6
NDC36987-2542
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 Strength10000 [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 36987-2542-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2542-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2542-1 [36987254201]

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

NDC 36987-2542-2 [36987254202]

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

NDC 36987-2542-3 [36987254203]

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

NDC 36987-2542-4 [36987254204]

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 POLLEN10000 [PNU]/mL

OpenFDA Data

SPL SET ID:3baaac54-68e4-47a3-b0c7-fb9b5b8d6271
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043675
  • 900876
  • 897980
  • 900927
  • 1044324
  • 895360
  • 895681
  • 1013925
  • 900955
  • 1013900
  • 1044385
  • 900966
  • 899982
  • 1044517
  • 900981
  • 900054
  • 1014716
  • 884183
  • 900718
  • 1044343
  • 883497
  • 900738
  • 1013885
  • 1044267
  • 1014320
  • 1043793
  • 895447
  • 1006480
  • 1014701
  • 889632
  • 900971
  • 900118
  • 1014446
  • 899600
  • 1014349
  • 899696
  • 898021
  • 1013957
  • 899966
  • 1013878
  • 307987
  • 1115276
  • 889560
  • 1043787
  • 897859
  • 1014682
  • 901503
  • 1044337
  • 895691
  • 1006474
  • 901023
  • 895376
  • 898130
  • 1044392
  • 1014309
  • 307966
  • 1044228
  • 901029
  • 1044398
  • 898415
  • 1044209
  • 899568
  • 900845
  • 1014266
  • 899583
  • 1044222
  • 895600
  • 899618
  • 897345
  • 1232582
  • 889645
  • 897557
  • 895706
  • 1232567
  • 898398
  • 897364
  • 1013947
  • 884079
  • 1299998
  • 897414
  • 895472
  • 898400
  • 1014444
  • 897412
  • 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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