Mold Mix A

Product NDC
0268-8109
11-digit product format
002688109
Labeler code
0268
Product ID
0268-8109_e013a85e-8896-42b7-b581-74695a9370b5
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, CLADOSPORIUM CLADOSPORIOIDES and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Substance
ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Active strength
.1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], 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
Mold Mix A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTERNARIA ALTERNATA.1 g/mL
ASPERGILLUS FUMIGATUS.1 g/mL
CLADOSPORIUM CLADOSPORIOIDES.1 g/mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM.1 g/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-8109-10Mold Mix A10 mL in 1 VIALINJECTION, SOLUTION103
0268-8109-50Mold Mix A53 mL in 1 VIALINJECTION, SOLUTION533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-8109MOLD MIX A (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, CLADOSPORIUM CLADOSPORIOIDES AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX B (EPICOCCUM NIGRUM, GIBBERELLA ZEAE AND MUCOR PLUMBEUS) INJECTION, SOLUTION MOLD MIX C (BOTRYTIS CINEREA, CANDIDA ALBICANS, RHODOTORULA MUCILAGINOSA, AND TRICHOPHYTON MENTAGROPHYTES) INJECTION, SOLUTION [ALK-ABELLO, INC.]3Current NDC, Legacy NDC, 2 package rows20230525_71dae77d-02e1-4dce-83e1-e7643c58f8fb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8109-100026881091010 mL in 1 VIAL (0268-8109-10) 10 ml1965-01-010000-00-00NoNoCurrent
0268-8109-500026881095053 mL in 1 VIAL (0268-8109-50) 53 ml1965-01-010000-00-00NoNoCurrent