NDC 49288-0056

Birch Mixture

Birch Mixture

Birch Mixture is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Betula Lenta Pollen; Betula Papyrifera Pollen; Betula Nigra Pollen; Betula Occidentalis Pollen; Betula Populifolia Pollen; Betula Alleghaniensis Pollen.

Product ID49288-0056_13c9eea1-38b5-472b-b735-a814ca886718
NDC49288-0056
Product TypeHuman Prescription Drug
Proprietary NameBirch Mixture
Generic NameBirch Mixture
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-23
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameBETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN
Active Ingredient Strength0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],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 Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0056-4

30 mL in 1 VIAL, MULTI-DOSE (49288-0056-4)
Marketing Start Date1974-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0056-4 [49288005604]

Birch Mixture INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0056-5 [49288005605]

Birch Mixture INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0056-1 [49288005601]

Birch Mixture INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0056-3 [49288005603]

Birch Mixture INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

NDC 49288-0056-2 [49288005602]

Birch Mixture INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1974-03-23
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
BETULA LENTA POLLEN.0083 g/mL

OpenFDA Data

SPL SET ID:3be2afc4-b2dc-4b0f-b314-5ade25922b66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 852327
  • 852323
  • 852656
  • 851739
  • 900948
  • 852719
  • 899596
  • 883495
  • 900843
  • 852712
  • 883416
  • 900116
  • 852817
  • 900753
  • 895356
  • 1299985
  • 897406
  • 903916
  • 852151
  • 852370
  • 851893
  • 852232
  • 900048
  • 852809
  • 883406
  • 900761
  • 900763
  • 900767
  • 1299990
  • 1299992
  • 899668
  • 851869
  • 852181
  • 852342
  • 897335
  • 852224
  • 852630
  • 900676
  • 900994
  • 901002
  • 852741
  • 852057
  • 851877
  • 852749
  • 900111
  • 852584
  • 1014194
  • 852351
  • 900707
  • 852625
  • 852453
  • 900064
  • 899614
  • 899616
  • 899694
  • 852580
  • 900780
  • 901018
  • 852753
  • 851913
  • 900711
  • 852592
  • 900714
  • 852366
  • 852196
  • 852612
  • 889650
  • 899553
  • 900799
  • 901021
  • 900095
  • 900093
  • 900791
  • 852297
  • 851905
  • 1115265
  • 852600
  • 852275
  • 852379
  • 852271
  • 900841
  • 852564
  • 900998
  • 852279
  • 852683
  • 1014758
  • 852165
  • 900773
  • 852169
  • 852284
  • 852672
  • 897982
  • 900734
  • 852263
  • 899648
  • 899579
  • 852572
  • 901014
  • 852422
  • 867300
  • 852177
  • 852305
  • 900134
  • 851747
  • 851743
  • 852499
  • 852494
  • 1013964
  • 897361
  • 899653
  • 899566
  • 899657
  • 901256
  • 900976
  • 901216
  • 900102
  • 900540
  • 900990
  • 852385
  • 852147
  • 852143
  • Pharmacological Class

    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • 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]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • 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 "Birch Mixture" or generic name "Birch Mixture"

    NDCBrand NameGeneric Name
    49288-0056Birch MixtureBirch Mixture
    49288-0057Birch MixtureBirch Mixture

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.