MIXED ASPERGILLUS

Product NDC
0268-6559
11-digit product format
002686559
Labeler code
0268
Product ID
0268-6559_5eb6b855-3ed0-42da-82cd-e5ed09dc7ca6
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
MIXED ASPERGILLUS
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Marketing end
0000-00-00
Substance
ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS TERREUS
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],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]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0268-6559DDiscontinued by firm2026-10-05
excluded packagepackage0268-65590268-6559-06DDiscontinued by firm2026-10-05

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0268-6559-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0268-6559-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0268-6559-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0268-6559-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0268-6559-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0268-6559-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0268-6559-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0268-6559-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0268-6559-06DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0268-6559-06DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0268-6559-06DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0268-6559-06DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0268-6559-06IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0268-6559-06EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0268-6559-062021-04-03C16284748780-1ab0b4bfd-9c35-d255-e053-dadaa90ae591Allergenic Extracts
0268-6559-062020-07-22C16284748780-1ab0b4bfd-9c35-d255-e053-dadaa90ae591Allergenic Extracts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPERGILLUS FLAVUS VAR. ORYZAEACTIVE INGREDIENTQ6Z8UK5R3GMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS NIGER VAR. NIGERACTIVE INGREDIENT9IOA40ANG6MIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS REPENSACTIVE INGREDIENTSQ89E6LOMEMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS TERREUSACTIVE INGREDIENTQBN8K7055XMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
TEA LEAFACTIVE INGREDIENTGH42T47V24MIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS FLAVUS VAR. ORYZAEACTIVE MOIETYQ6Z8UK5R3GMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS NIGER VAR. NIGERACTIVE MOIETY9IOA40ANG6MIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS REPENSACTIVE MOIETYSQ89E6LOMEMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
ASPERGILLUS TERREUSACTIVE MOIETYQBN8K7055XMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
TEA LEAFACTIVE MOIETYGH42T47V24MIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMIXED ASPERGILLUS INJECTION, SOLUTION THEA SIRENSIS INJECTION, SOLUTION [ALK-ABELLO, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-6559-06002686559065 mL in 1 VIAL (0268-6559-06) 5 ml1965-01-010000-00-00NoNoCurrent