Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus

Product NDC: 22840-0040
Requested package NDC: 22840-0040-9
11-digit product format: 228400040
Labeler code: 22840
Product ID: 22840-0040_94191d1d-9858-602a-e053-2a95a90aa50f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dermatophagoides farinae and Dermatophagoides pteronyssinus
Dosage form: CONCENTRATE
Route: INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Labeler: Greer Laboratories, Inc.
Application: BLA101834
Marketing category: BLA
Marketing start: 2010-02-03
Marketing end: 0000-00-00
Substance: DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
Active strength: 15000 [AU]/mL; [AU]/mL
Pharmacologic classes: Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	22840-0040	22840-0040-9	D	Discontinued by firm		2026-09-09

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 · 6 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…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Standardized Mite Dermatophagoides farinae	DERMATOPHAGOIDES FARINAE	Greer Laboratories, Inc.	9b7f878e-613f-4831-9223-a6a07fb09f1b	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA101834

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
101834		Insects (Whole Body), Mite Dermatophagoides farinae	351(a)	Rx	2026-08-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
PR9U2YPF3Q	DERMATOPHAGOIDES FARINAE	DERMATOPHAGOIDES FARINAE
57L1Z5378K	DERMATOPHAGOIDES PTERONYSSINUS	DERMATOPHAGOIDES PTERONYSSINUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
22840-0040-9	22840004009	50 mL in 1 VIAL, MULTI-DOSE (22840-0040-9)	50 ml	2010-02-03	0000-00-00	No	No	Current