MIXED PENICILLIUM

Product NDC
0268-8051
11-digit product format
002688051
Labeler code
0268
Product ID
0268-8051_54520d8e-459d-481c-92b9-287e37987516
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1998-02-23
Marketing end
0000-00-00
Substance
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
Active strength
0 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]
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 productproduct0268-8051DDiscontinued by firm2026-08-17
excluded packagepackage0268-80510268-8051-06DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0268-8051-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0268-8051-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0268-8051-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0268-8051-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0268-8051-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0268-8051-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0268-8051-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0268-8051-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0268-8051-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0268-8051-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0268-8051-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0268-8051-06557ba5c1ecfa…9c80585c8c6e…

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
0268-8051-06MIXED PENICILLIUM5.5 mL in 1 VIALINJECTION, SOLUTION5.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-8051SORREL/DOCK MIX (RUMEX ACETOSELLA POLLEN AND RUMEX CRISPUS POLLEN) INJECTION, SOLUTION MIXED MOLDS (ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MIXED PENICILLIUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MIXED RAGWEED (AMBROSIA ARTEMISIIFOLIA AND AMBROSIA TRIFIDA POLLEN) INJECTION, SOLUTION MOLD MIX 2 (AUREOBASIDIUM PULLULANS VAR. PULLUTANS, CURVULARIA INAEQUALIS, GIBBERELLA ZEAE, MUCOR PLUMBEUS AND RHIZOPUS ARRHIZUS) INJECTION, SOLUTION [ALK-ABELLO, INC.]7Legacy NDC, 1 package rows20230526_855a5ae8-fa7a-4e0a-a82b-21523bd77233.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896177giant ragweed pollen extract 50 MG/ML / short ragweed pollen extract 50 MG/ML Injectable SolutionPSN855a5ae8-fa7a-4e0a-a82b-21523bd772337
1942011Penicillium chrysogenum var. chrysogenum extract 0.2 GM/ML Injectable SolutionPSN855a5ae8-fa7a-4e0a-a82b-21523bd772337
901487sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable SolutionPSN855a5ae8-fa7a-4e0a-a82b-21523bd772337
896177giant ragweed pollen extract 50 MG/ML / western ragweed pollen extract 50 MG/ML Injectable SolutionSCD855a5ae8-fa7a-4e0a-a82b-21523bd772337
1942011Penicillium chrysogenum var. chrysogenum allergenic extract 200 MG/ML Injectable SolutionSCD855a5ae8-fa7a-4e0a-a82b-21523bd772337
901487sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable SolutionSCD855a5ae8-fa7a-4e0a-a82b-21523bd772337
896177Ambrosia artemisiifolia pollen extract 0.05 GM/ML / Ambrosia trifida pollen extract 0.05 GM/ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337
896177Ambrosia artemisiifolia pollen extract 50 MG/ML / Ambrosia trifida pollen extract 50 MG/ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337
1942011Penicillium chrysogenum var. chrysogenum extract 0.2 GM/ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337
1942011Penicillium notatum allergenic extract 0.2 GM/ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337
901487Rumex acetosella pollen extract 0.05 GM / Rumex crispus pollen extract 0.05 GM per ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337
901487Rumex acetosella pollen extract 50 MG / Rumex crispus pollen extract 50 MG per ML Injectable SolutionSY855a5ae8-fa7a-4e0a-a82b-21523bd772337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8051-06002688051065.5 mL in 1 VIAL (0268-8051-06) 5.5 ml1998-02-230000-00-00NoNoCurrent