Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus

Product NDC
22840-0040
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct22840-0040DDiscontinued by firm2026-09-09
excluded packagepackage22840-004022840-0040-6DDiscontinued by firm2026-09-09
excluded packagepackage22840-004022840-0040-8DDiscontinued by firm2026-09-09
excluded packagepackage22840-004022840-0040-9DDiscontinued by firm2026-09-09

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 · 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 packagepackage22840-0040-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage22840-0040-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage22840-0040-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage22840-0040-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage22840-0040-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage22840-0040-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage22840-0040-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage22840-0040-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage22840-0040-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage22840-0040-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage22840-0040-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage22840-0040-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage22840-0040-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage22840-0040-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage22840-0040-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage22840-0040-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage22840-0040-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage22840-0040-9cdf11ea48f46…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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Standardized Mite Dermatophagoides farinaeDERMATOPHAGOIDES FARINAEGreer Laboratories, Inc.9b7f878e-613f-4831-9223-a6a07fb09f1b2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA101834

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101834Insects (Whole Body), Mite Dermatophagoides farinae351(a)Rx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
22840-0040-62284000400610 mL in 1 VIAL, MULTI-DOSE (22840-0040-6) 10 ml2010-02-030000-00-00NoNoCurrent
22840-0040-82284000400830 mL in 1 VIAL, MULTI-DOSE (22840-0040-8) 30 ml2010-02-030000-00-00NoNoCurrent
22840-0040-92284000400950 mL in 1 VIAL, MULTI-DOSE (22840-0040-9) 50 ml2010-02-030000-00-00NoNoCurrent