STANDARDIZED MITE, MIXED
- Product NDC
- 0268-8116
- 11-digit product format
- 002688116
- Labeler code
- 0268
- Product ID
- 0268-8116_0922c304-5b4a-4bb6-a9f2-a3603ec2e7ba
- Type
- STANDARDIZED ALLERGENIC
- Nonproprietary name
- DERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS
- Dosage form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103060
- Marketing category
- BLA
- Marketing start
- 1991-07-08
- Substance
- DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 5000; 5000 [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 | 5000 [AU]/mL |
| DERMATOPHAGOIDES PTERONYSSINUS | 5000 [AU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-8116-06 | STANDARDIZED MITE, MIXED | 5.5 mL in 1 VIAL | INJECTION, SOLUTION | 5.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0268-8116 | STANDARDIZED MITE, MIXED (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20200205_56f6254a-1406-4dbd-87ce-5b97dcebd03b.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 |
|---|
| 0268-8116-06 | 00268811606 | 5.5 mL in 1 VIAL (0268-8116-06) | 5.5 ml | 1991-07-08 | 0000-00-00 | No | No | Current |