Standardized Mite, Mixed
- Product NDC
- 0268-7003
- 11-digit product format
- 002687003
- Labeler code
- 0268
- Product ID
- 0268-7003_0d272bb1-4853-4bef-a694-5aef113225e6
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- Standardized Mite, Mixed
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103060
- Marketing category
- BLA
- Marketing start
- 1991-07-08
- Marketing end
- 0000-00-00
- Substance
- DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 5000 [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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-7003-30 | Standardized Mite, Mixed | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DERMATOPHAGOIDES FARINAE | ACTIVE INGREDIENT | PR9U2YPF3Q | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| DERMATOPHAGOIDES PTERONYSSINUS | ACTIVE INGREDIENT | 57L1Z5378K | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| DERMATOPHAGOIDES FARINAE | ACTIVE MOIETY | PR9U2YPF3Q | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| DERMATOPHAGOIDES PTERONYSSINUS | ACTIVE MOIETY | 57L1Z5378K | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0268-7003 | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 5 | Legacy NDC, 1 package rows | 20200221_4a3539da-7f51-401b-8ac2-101b8a4658f4.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103060 | | Insects (Whole Body), Mite Dermatophagoides farinae | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 0268-7003-30 | 00268700330 | 30 mL in 1 VIAL (0268-7003-30) | 30 ml | 1991-07-08 | 0000-00-00 | No | No | Current |