Home NDC 0268-8113-10 Mold Mix C
Product NDC 0268-8113
Requested package NDC 0268-8113-10
11-digit product format 002688113
Labeler code 0268
Product ID 0268-8113_d249fd8b-a49a-4693-88da-09872cf48bb4
Type NON-STANDARDIZED ALLERGENIC
Nonproprietary name BOTRYTIS CINEREA, CANDIDA ALBICANS, RHODOTORULA MUCILAGINOSA, and TRICHOPHYTON MENTAGROPHYTES
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler ALK-Abello, Inc.
Application BLA103753
Marketing category BLA
Marketing start 1965-01-01
Marketing end 0000-00-00
Substance BOTRYTIS CINEREA; RHODOTORULA MUCILAGINOSA; CANDIDA ALBICANS; TRICHOPHYTON MENTAGROPHYTES
Active strength 0 g/mL; g/mL; g/mL; g/mL
Pharmacologic classes Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-8113-10 Mold Mix C 10 mL in 1 VIAL INJECTION, SOLUTION 10 3 0268-8113-50 Mold Mix C 53 mL in 1 VIAL INJECTION, SOLUTION 53 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-8113 MOLD 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.] 3 Legacy NDC, 2 package rows 20230525_71dae77d-02e1-4dce-83e1-e7643c58f8fb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-8113-10 00268811310 10 mL in 1 VIAL (0268-8113-10) 10 ml 1965-01-01 0000-00-00 No No Current