Standardized Mite, Dermatophagoides farinae
- Product NDC
- 49288-0175
- 11-digit product format
- 492880175
- Labeler code
- 49288
- Product ID
- 49288-0175_745162a9-2fdc-4b03-a3bc-32d410b3d9c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Standardized Mite, Dermatophagoides farinae
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102224
- Marketing category
- BLA
- Marketing start
- 1991-10-22
- Marketing end
- 0000-00-00
- Substance
- DERMATOPHAGOIDES FARINAE
- Active strength
- 10000 [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]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 49288-0175-1 | Standardized Mite, Dermatophagoides farinae | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 3 |
| 49288-0175-2 | Standardized Mite, Dermatophagoides farinae | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 3 |
| 49288-0175-3 | Standardized Mite, Dermatophagoides farinae | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 49288-0175-4 | Standardized Mite, Dermatophagoides farinae | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | | 3 |
| 49288-0175-5 | Standardized Mite, Dermatophagoides farinae | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dermatophagoides farinae | ACTIVE INGREDIENT | PR9U2YPF3Q | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Dermatophagoides pteronyssinus | ACTIVE INGREDIENT | 57L1Z5378K | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Dermatophagoides farinae | ACTIVE MOIETY | PR9U2YPF3Q | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Dermatophagoides pteronyssinus | ACTIVE MOIETY | 57L1Z5378K | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Sodium Bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49288-0175 | STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE INJECTION, SOLUTION MIXTURE OF STANDARDIZED MITES INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 3 | Legacy NDC, 5 package rows | 20090917_3b3cb12c-65d3-46ab-9bac-82c569a76220.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 49288-0175-1 | 49288017501 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | Historical |
| 49288-0175-2 | 49288017502 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |
| 49288-0175-3 | 49288017503 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 49288-0175-4 | 49288017504 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 49288-0175-5 | 49288017505 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |