House Dust Mite, Dermatophagoides pteronyssinus
- Product NDC
- 49643-704
- 11-digit product format
- 496430704
- Labeler code
- 49643
- Product ID
- 49643-704_36ad59b6-cc4b-fe11-e063-6394a90ac650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- House Dust Mite, Dermatophagoides pteronyssinus
- Dosage form
- INJECTION
- Route
- CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
- Labeler
- Allermed Laboratories, Inc.
- Application
- BLA102213
- Marketing category
- BLA
- Marketing start
- 1986-12-24
- Substance
- DERMATOPHAGOIDES PTERONYSSINUS
- Active strength
- 10000 [AU]/mL
- Pharmacologic classes
- Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], 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
- House Dust Mite, Dermatophagoides pteronyssinus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DERMATOPHAGOIDES PTERONYSSINUS | 10000 [AU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PR9U2YPF3Q, 57L1Z5378K |
| Rxcui | 852825, 852829 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49643-704-05 | House Dust Mite, Dermatophagoides pteronyssinus | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 5 |
| 49643-704-10 | House Dust Mite, Dermatophagoides pteronyssinus | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 5 |
| 49643-704-30 | House Dust Mite, Dermatophagoides pteronyssinus | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 5 |
| 49643-704-50 | House Dust Mite, Dermatophagoides pteronyssinus | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION | 50 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DERMATOPHAGOIDES FARINAE | ACTIVE INGREDIENT | PR9U2YPF3Q | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| DERMATOPHAGOIDES PTERONYSSINUS | ACTIVE INGREDIENT | 57L1Z5378K | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| DERMATOPHAGOIDES FARINAE | ACTIVE MOIETY | PR9U2YPF3Q | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| DERMATOPHAGOIDES PTERONYSSINUS | ACTIVE MOIETY | 57L1Z5378K | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| Phenol | INACTIVE INGREDIENT | 339NCG44TV | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| Sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49643-704 | HOUSE DUST MITE, DERMATOPHAGOIDES FARINAE INJECTION HOUSE DUST MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION [ALLERMED LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250119_3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6.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 |
|---|
| 49643-704-05 | 49643070405 | 5 mL in 1 VIAL, MULTI-DOSE (49643-704-05) | 5 ml | 1986-12-24 | 0000-00-00 | No | No | Current |
| 49643-704-10 | 49643070410 | 10 mL in 1 VIAL, MULTI-DOSE (49643-704-10) | 10 ml | 1986-12-24 | 0000-00-00 | No | No | Current |
| 49643-704-30 | 49643070430 | 30 mL in 1 VIAL, MULTI-DOSE (49643-704-30) | 30 ml | 1986-12-24 | 0000-00-00 | No | No | Current |
| 49643-704-50 | 49643070450 | 50 mL in 1 VIAL, MULTI-DOSE (49643-704-50) | 50 ml | 1986-12-24 | 0000-00-00 | No | No | Current |