Home NDC 0268-8049-10 MIXED MOLDS
Product NDC 0268-8049
Requested package NDC 0268-8049-10
11-digit product format 002688049
Labeler code 0268
Product ID 0268-8049_cbda3a30-3992-49ce-b24e-98b61dad0c89
Type NON-STANDARDIZED ALLERGENIC
Nonproprietary name ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler ALK-Abello, Inc.
Application BLA103753
Marketing category BLA
Marketing start 1998-02-23
Marketing end 0000-00-00
Substance ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Active strength 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/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],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],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 2022-12-31
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 0268-8049-10 MIXED MOLDS 10.5 mL in 1 VIAL INJECTION, SOLUTION 10.5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-8049 MIXED ASPERGILLUS (ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER) INJECTION, SOLUTION MIXED MOLDS (ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION MIXED PENICILLIUM (PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION 10 TREE MIX (ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION BIRCH MIX (BETULA NIGRA, BETULA POPULIFOLIA) INJECTION, SOLUTION [ALK-ABELLO, 8 Legacy NDC, 1 package rows 20230602_1f7f1612-c7b2-4948-b35b-fcaa92de8989.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-8049-10 00268804910 10.5 mL in 1 VIAL (0268-8049-10) 10.5 ml 1998-02-23 0000-00-00 No No Current