MIDWEST MOLDS

Product NDC
0268-8039
11-digit product format
002688039
Labeler code
0268
Product ID
0268-8039_25c99df0-1f9c-45e1-950b-88e8cb11ed1d
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
CHAETOMIUM GLOBOSUM, COCHLIOBOLUS SATIVUS, GIBBERELLA ZEAE, MUCOR PLUMBEUS, PHOMA EXIGUA VAR. EXIGUA, RHIZOPUS ARRHIZUS VAR. ARRHIZUS
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
COCHLIOBOLUS SATIVUS; CHAETOMIUM GLOBOSUM; GIBBERELLA ZEAE; MUCOR PLUMBEUS; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS ARRHIZUS
Active strength
20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharmacologic classes
Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],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

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 productproduct0268-8039DDiscontinued by firm2026-08-03
excluded packagepackage0268-80390268-8039-50DDiscontinued by firm2026-08-03

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 packagepackage0268-8039-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0268-8039-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0268-8039-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0268-8039-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0268-8039-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0268-8039-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0268-8039-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0268-8039-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0268-8039-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0268-8039-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0268-8039-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0268-8039-50557ba5c1ecfa…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
0268-8039-50MIDWEST MOLDS53 mL in 1 VIALINJECTION, SOLUTION535

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-8039MIXED ASPERGILLUS (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER, GALLUS GALLUS FEATHER) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) .......NUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX 2 (AUREOBASIDIUM PULLULANS, CURVULARIA INAEQUALIS, FUSARIUM ROSEUM, MUCOR PLUMBEUS, PHIZOPUS ORYZAE) INJECTION, SOLUTION FAPP MIXTURE (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, GIBBERELLA ZEAE, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PHOMA EXIGUA VAR. EXIGUA) INJECTION, SOLUTION [ALK-ABELLO, INC.]5Legacy NDC, 1 package rows20230525_5f15c12a-8df0-41de-9d59-7de47e5e89ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922788giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum allergenic extract 20,000 UNT/mL Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum allergenic extract 40,000 UNT/mL Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum allergenic extract 20000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum allergenic extract 40000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791Ambrosia artemisiifolia pollen extract 40000 PNU/ML / Ambrosia trifida pollen extract 40000 PNU/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791Ambrosia artemisiifolia pollen extract 40000 UNT/ML / Ambrosia trifida pollen extract 40000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797Carya illinoinensis pollen UNT/ML / Carya ovata pollen extract 100 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum extract 20,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum extract 40,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium notatum allergenic extract 20,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium notatum allergenic extract 40,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8039-500026880395053 mL in 1 VIAL (0268-8039-50) 53 ml1965-01-010000-00-00NoNoCurrent