NDC 49288-0328

Nigrospora

Nigrospora

Nigrospora 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 Khuskia Oryzae.

Product ID49288-0328_272c9910-2160-4d41-afbd-faab3055ba1d
NDC49288-0328
Product TypeHuman Prescription Drug
Proprietary NameNigrospora
Generic NameNigrospora
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-23
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameKHUSKIA ORYZAE
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0328-1

2 mL in 1 VIAL, MULTI-DOSE (49288-0328-1)
Marketing Start Date1974-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0328-1 [49288032801]

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

NDC 49288-0328-3 [49288032803]

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

NDC 49288-0328-5 [49288032805]

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

NDC 49288-0328-4 [49288032804]

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

NDC 49288-0328-2 [49288032802]

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

Drug Details

Active Ingredients

IngredientStrength
KHUSKIA ORYZAE.05 g/mL

OpenFDA Data

SPL SET ID:6d2006e2-55ea-41db-bd17-ce6d080f28a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1232665
  • 1232664
  • 854133
  • 1006282
  • 852401
  • 1232661
  • 1006288
  • 852243
  • 905075
  • 314941
  • 968126
  • 995702
  • 968128
  • 889590
  • 852394
  • 1011972
  • 1014388
  • 1012051
  • 1012035
  • 852131
  • 892348
  • 1192733
  • 967724
  • 883483
  • 883481
  • 892341
  • 905073
  • 852060
  • 883409
  • 968440
  • 966660
  • 1006300
  • 852105
  • 966984
  • 966982
  • 1014440
  • 1192974
  • 1192972
  • 1006313
  • 968495
  • 1014754
  • 901848
  • 966993
  • 967051
  • 966998
  • 852192
  • 1192996
  • 968544
  • 967985
  • 968429
  • 967038
  • 968425
  • 967036
  • 968420
  • 967030
  • 1014748
  • 852041
  • 852690
  • 967777
  • 905091
  • 967049
  • 968416
  • 967963
  • 967000
  • 967967
  • 967969
  • 852375
  • 968406
  • 968404
  • 1192735
  • 1193007
  • 1193001
  • 1094477
  • 967761
  • 968814
  • 967053
  • 995697
  • 852469
  • 1014761
  • 966946
  • 966695
  • 968470
  • 967061
  • 1193013
  • 968478
  • 1010904
  • 968509
  • 967947
  • 904834
  • 967371
  • 1014402
  • 968505
  • 1014410
  • 995730
  • 967032
  • 1014390
  • 1014394
  • 1012047
  • 1014398
  • 968117
  • Pharm Class PE
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
  • PHarm Class EPC
  • Non-Standardized Fungal Allergenic Extract [EPC]
  • NUI Code
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nigrospora" or generic name "Nigrospora"

    NDCBrand NameGeneric Name
    49288-0327NigrosporaNigrospora
    49288-0328NigrosporaNigrospora

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