Home NDC 0268-0278 Standardized Mite D. pteronyssinus
Product NDC 0268-0278
11-digit product format 002680278
Labeler code 0268
Product ID 0268-0278_6ec0580a-501c-4759-818b-9fb7a15611ef
Type STANDARDIZED ALLERGENIC
Nonproprietary name Standardized Mite D. pteronyssinus
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler ALK-Abello, Inc.
Application BLA103752
Marketing category BLA
Marketing start 1990-08-14
Marketing end 0000-00-00
Substance DERMATOPHAGOIDES PTERONYSSINUS
Active strength 5000 [AU]/mL
Pharmacologic classes 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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-0278-10 Standardized Mite D. pteronyssinus 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 7 0268-0278-30 Standardized Mite D. pteronyssinus 30 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DERMATOPHAGOIDES FARINAE ACTIVE INGREDIENT PR9U2YPF3Q STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 DERMATOPHAGOIDES PTERONYSSINUS ACTIVE INGREDIENT 57L1Z5378K STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 DERMATOPHAGOIDES FARINAE ACTIVE MOIETY PR9U2YPF3Q STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 DERMATOPHAGOIDES PTERONYSSINUS ACTIVE MOIETY 57L1Z5378K STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-0278 STANDARDIZED MITE D. FARINAE INJECTION, SOLUTION STANDARDIZED MITE D. FARINAE SOLUTION STANDARDIZED MITE D. PTERONYSSINUS INJECTION, SOLUTION [ALK-ABELLO, INC.] 7 Legacy NDC, 2 package rows 20220811_cbe1d24d-df77-4940-baf8-623993fa731b.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103752 Insects (Whole Body), Mite Dermatophagoides pteronyssinus 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-0278-10 00268027810 10 mL in 1 VIAL, MULTI-DOSE (0268-0278-10) 10 ml 1990-08-14 0000-00-00 No No Current 0268-0278-30 00268027830 30 mL in 1 VIAL, MULTI-DOSE (0268-0278-30) 30 ml 1990-08-14 0000-00-00 No No Current 0268-0278-50 00268027850 50 mL in 1 VIAL, MULTI-DOSE (0268-0278-50) 50 ml 1990-08-14 0000-00-00 No No Current