Standardized Mite, Mixed
- Product NDC
- 0268-7002
- 11-digit product format
- 002687002
- Labeler code
- 0268
- Product ID
- 0268-7002_99cfd9aa-141f-48cf-8b7f-41f0d6891749
- 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
- Substance
- DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 10000; 10000 [AU]/mL; [AU]/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Standardized Mite, Mixed
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DERMATOPHAGOIDES FARINAE | 10000 [AU]/mL |
| DERMATOPHAGOIDES PTERONYSSINUS | 10000 [AU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-7002-10 | Standardized Mite, Mixed | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 6 |
| 0268-7002-50 | Standardized Mite, Mixed | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 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 |
|---|
| 0268-7002 | STANDARDIZED MITE, MIXED INJECTION, SOLUTION [ALK-ABELLO, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20200221_4a3539da-7f51-401b-8ac2-101b8a4658f4.zip |
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 |
|---|
| 0268-7002-10 | 00268700210 | 10 mL in 1 VIAL (0268-7002-10) | 10 ml | 1991-07-08 | 0000-00-00 | No | No | Current |
| 0268-7002-30 | 00268700230 | 30 mL in 1 VIAL (0268-7002-30) | 30 ml | 1991-07-08 | 0000-00-00 | No | No | Current |
| 0268-7002-50 | 00268700250 | 50 mL in 1 VIAL (0268-7002-50) | 50 ml | 1991-07-08 | 0000-00-00 | No | No | Current |