CANDIDA ALBICANS

Product NDC
0268-8092
11-digit product format
002688092
Labeler code
0268
Product ID
0268-8092_85c04c83-76ad-4116-aeb7-bbb5a9ab23f3
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
CANDIDA ALBICANS
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Substance
CANDIDA ALBICANS
Active strength
.1 g/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CANDIDA ALBICANS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANDIDA ALBICANS.1 g/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-8092-10CANDIDA ALBICANS10.5 mL in 1 VIALINJECTION, SOLUTION10.53
0268-8092-50CANDIDA ALBICANS53 mL in 1 VIALINJECTION, SOLUTION533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-8092SAROCLADIUM STRICTUM INJECTION, SOLUTION ALTERNARIA ALTERNATA INJECTION, SOLUTION ASPERGILLUS FUMIGATUS INJECTION, SOLUTION AUREOBASIDIUM PULLULANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) INJECTION, SOLUTION BIPOLARIS SOROKINIANA (COCHLIOBOLUS SATIVUS) INJECTION, SOLUTION BOTRYTIS CINEREA INJECTION, SOLUTION CANDIDA ALBICANS INJECTION, SOLUTION CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION EPICOCCUM NIGRUM INJECTION, SOLUTION GIBBERELLA PULICARIS (GIBBERELLA ZEAE) INJECTION, SOLUTION MUCOR PLUMBEUS INJECTION, SOLUTION PENICILLIUM NOTATUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION RHODOTORULA MUCILAGINOSA INJECTION, SOLUTION TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION [ALK-ABELLO, INC.]3Current NDC, Legacy NDC, 2 package rows20230525_f47f8c82-205f-49c6-befa-d5beb55eb6bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905075Acremonium strictum allergenic extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
901848Alternaria alternata allergenic extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852060Aspergillus fumigatus extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852192Botrytis cinerea allergenic extract 100 MG/mL Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967032Candida albicans extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967053Cladosporium cladosporioides extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852401Cochliobolus sativus extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852469Epicoccum nigrum extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967869Mucor plumbeus allergenic extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
854133Penicillium chrysogenum var. chrysogenum extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852105Pullularia extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967534Rhodotorula mucilaginosa extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
889587Trichophyton mentagrophytes extract 100 MG/ML Injectable SolutionPSNf47f8c82-205f-49c6-befa-d5beb55eb6bd3
905075Acremonium strictum allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
901848Alternaria alternata allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852060Aspergillus fumigatus allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852105Aureobasidium pullulans var. pullutans allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852192Botrytis cinerea allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967032Candida albicans allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967053Cladosporium cladosporioides extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852401Cochliobolus sativus allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852469Epicoccum nigrum allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967869Mucor plumbeus allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
854133Penicillium chrysogenum var. chrysogenum allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967534Rhodotorula mucilaginosa allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
889587Trichophyton mentagrophytes allergenic extract 100 MG/ML Injectable SolutionSCDf47f8c82-205f-49c6-befa-d5beb55eb6bd3
905075Acremonium strictum allergenic extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
901848Alternaria alternata allergenic extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
901848Alternaria tenuis allergenic extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852060Aspergillus fumigatus extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852105Aureobasidium pullulans var. pullutans extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852105Aureobasidium pullulans var. pullutans extract 100 MG/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852192Botrytis cinerea extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967032Candida albicans extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967053Cladosporium cladosporioides extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852401Cochliobolus (Helminthopsorium) sativus extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852401Cochliobolus (Helminthopsorium) sativus extract 100 MG/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
852469Epicoccum nigrum extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967869Mucor plumbeus extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
854133Penicillium chrysogenum var. chrysogenum extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
854133Penicillium notatum allergenic extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
967534Rhodotorula mucilaginosa extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
905075Sarocladium strictum allergenic extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3
889587Trichophyton mentagrophytes extract 0.1 GM/ML Injectable SolutionSYf47f8c82-205f-49c6-befa-d5beb55eb6bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8092-100026880921010.5 mL in 1 VIAL (0268-8092-10) 10.5 ml1965-01-010000-00-00NoNoCurrent
0268-8092-500026880925053 mL in 1 VIAL (0268-8092-50) 53 ml1965-01-010000-00-00NoNoCurrent