MOLD MIX Number 1

Product NDC: 0268-8066
11-digit product format: 002688066
Labeler code: 0268
Product ID: 0268-8066_b90d09e0-d2ab-4d48-90fe-d4344c0ffefa
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, CLADOSPORIUM SPHAEROSPERMUM, COCHLIOBOLUS SATIVUS and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
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: PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; COCHLIOBOLUS SATIVUS; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM SPHAEROSPERMUM
Active strength: 10000 [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],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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0268-8066		D	Discontinued by firm		2026-08-11
excluded package	package	0268-8066	0268-8066-50	D	Discontinued by firm		2026-08-11

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0268-8066-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0268-8066-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0268-8066-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0268-8066-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0268-8066-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0268-8066-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0268-8066-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0268-8066-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0268-8066-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0268-8066-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0268-8066-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0268-8066-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0268-8066-50	MOLD MIX Number 1	53 mL in 1 VIAL	INJECTION, SOLUTION	53		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0268-8066	OAK MIX (QUERCUS RUBRA, QUERCUS ALBA, QUERCUS VIRGINIANA) INJECTION, SOLUTION 9 TREE MIX (ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN AND ULMUS CRASSIFOLIA POLLEN) INJECTION, SOLUTION HICKORY PECAN MIX (CARYA ILLINOINENSIS POLLEN AND CARYA OVATA POLLEN) INJECTION, SOLUTION MAPLE MIX (ACER NEGUNDO POLLEN AND ACER RUBRUM POLLEN) INJECTION, SOLUTION MIXED COCKROACH (BLATELLA GERMANICA AND PERIPLANETA AMERICANA) INJECTION, SOLUTION MIXED WEEDS (CHENOPODIUM ALBUM POLLEN, IVA ANNUA POLLEN, LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION MOLD MIX NUMBER 1 (ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, CLADOSPORIUM SPHAEROSPERMUM, COCHLIOBOLUS SATIVUS AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION WEED MIX NUMBER 7B (AMARANTHUS RETROFLEXUS POLLEN, ARTEMISIA VULGARIS ROOT, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, RUME	4	Legacy NDC, 1 package rows	20230601_7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
3Y1PE1GCIG	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
3LN5B70U4W	COCHLIOBOLUS SATIVUS	COCHLIOBOLUS SATIVUS
52B29REC7H	ALTERNARIA ALTERNATA	ALTERNARIA ALTERNATA
9IOA40ANG6	ASPERGILLUS NIGER VAR. NIGER	ASPERGILLUS NIGER VAR. NIGER
P87YCA1U8R	CLADOSPORIUM SPHAEROSPERMUM	CLADOSPORIUM SPHAEROSPERMUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1735534	American cockroach allergenic extract 50 MG/mL / German cockroach allergenic extract 50 MG/mL Injectable Solution	PSN	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	PSN	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	PSN	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
901487	sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable Solution	PSN	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1735534	American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable Solution	SCD	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	SCD	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	SCD	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
901487	sheep sorrel pollen extract 50 MG/ML / yellow dock pollen extract 50 MG/ML Injectable Solution	SCD	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927623	Acer negundo pollen extract 0.05 GM/ML / Acer rubrum pollen extract 0.05 GM/ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927623	Acer negundo pollen extract 50 MG/ML / Acer rubrum pollen extract 50 MG/ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927683	Carya illinoinensis pollen 0.05 GM/ML / Carya ovata pollen extract 0.05 GM/ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1927683	Carya illinoinensis pollen 50 MG/ML / Carya ovata pollen extract 50 MG/ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
1735534	Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
901487	Rumex acetosella pollen extract 0.05 GM / Rumex crispus pollen extract 0.05 GM per ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4
901487	Rumex acetosella pollen extract 50 MG / Rumex crispus pollen extract 50 MG per ML Injectable Solution	SY	7ddb1a19-a904-4dcf-b684-bf7fedd0c7c1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0268-8066-50	00268806650	53 mL in 1 VIAL (0268-8066-50)	53 ml	1998-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERAPEUTIC ALLERGENIC EXTRACTS- Glycerin Products	ALK-Abello, Inc.	2023-05-30	NON-STANDARDIZED ALLERGENIC LABEL	4