NDC 0268-0845

CANDIDA ALBICANS

Candida Albicans

CANDIDA ALBICANS is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Candida Albicans.

Product ID0268-0845_152accc2-8563-4b11-9c7c-f61b002b30f8
NDC0268-0845
Product TypeNon-standardized Allergenic
Proprietary NameCANDIDA ALBICANS
Generic NameCandida Albicans
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameCANDIDA ALBICANS
Active Ingredient Strength40000 [PNU]/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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0268-0845-50

50 mL in 1 VIAL, MULTI-DOSE (0268-0845-50)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-0845-50 [00268084550]

CANDIDA ALBICANS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-0845-10 [00268084510]

CANDIDA ALBICANS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
CANDIDA ALBICANS40000 [PNU]/mL

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 "CANDIDA ALBICANS" or generic name "Candida Albicans"

NDCBrand NameGeneric Name
0220-1118Candida albicansCANDIDA ALBICANS
0220-1119Candida albicansCANDIDA ALBICANS
0220-1123Candida albicansCANDIDA ALBICANS
0220-1126Candida albicansCANDIDA ALBICANS
0220-1127Candida albicansCANDIDA ALBICANS
0220-1130Candida albicansCANDIDA ALBICANS
0220-1131Candida albicansCANDIDA ALBICANS
0220-1133Candida albicansCANDIDA ALBICANS
0220-1134Candida albicansCANDIDA ALBICANS
0220-1135Candida albicansCANDIDA ALBICANS
0220-6413Candida albicansCANDIDA ALBICANS
0268-0842CANDIDA ALBICANSCANDIDA ALBICANS
0268-0843CANDIDA ALBICANSCANDIDA ALBICANS
0268-0844CANDIDA ALBICANSCANDIDA ALBICANS
0268-0845CANDIDA ALBICANSCANDIDA ALBICANS
0268-0846CANDIDA ALBICANSCANDIDA ALBICANS
0268-0847CANDIDA ALBICANSCANDIDA ALBICANS
0268-0848CANDIDA ALBICANSCANDIDA ALBICANS
0268-0849CANDIDA ALBICANSCANDIDA ALBICANS
0268-0850CANDIDA ALBICANSCANDIDA ALBICANS
0268-6514CANDIDA ALBICANSCandida albicans
0268-6515CANDIDA ALBICANSCandida albicans
0268-8092CANDIDA ALBICANSCANDIDA ALBICANS
68428-283Candida albicansCandida albicans
71919-156Candida albicansCandida albicans
22840-1641Candida albicansCandida albicans
22840-1643Candida albicansCandida albicans
22840-1644Candida albicansCandida albicans
22840-1640Candida albicansCandida albicans
22840-5610Candida albicansCandida albicans
22840-1646Candida albicansCandida albicans
22840-1642Candida albicansCandida albicans
36987-1913Candida albicansCandida albicans
36987-1919Candida albicansCandida albicans
36987-1916Candida albicansCandida albicans
36987-1912Candida albicansCandida albicans
36987-1917Candida albicansCandida albicans
36987-1914Candida albicansCandida albicans
36987-1911Candida albicansCandida albicans
36987-1915Candida albicansCandida albicans
36987-1918Candida albicansCandida albicans
49288-0313Candida albicansCandida albicans
49288-0312Candida albicansCandida albicans
49288-0314Candida albicansCandida albicans
0268-8093CANDIDA ALBICANSCANDIDA ALBICANS
62106-6754CANDIDA ALBICANSCANDIDA ALBICANS

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