Sole
- Product NDC
- 49288-0473
- 11-digit product format
- 492880473
- Labeler code
- 49288
- Product ID
- 49288-0473_38eb8027-2cc3-42f8-ad39-70588a8bd791
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102223
- Marketing category
- BLA
- Marketing start
- 1974-03-23
- Marketing end
- 0000-00-00
- Substance
- ENGLISH SOLE
- Active strength
- 0 g/mL
- Pharmacologic classes
- Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]
- 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 |
|---|
| 49288-0473-1 | Sole | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 1 |
| 49288-0473-2 | Sole | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 1 |
| 49288-0473-3 | Sole | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 49288-0473-4 | Sole | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | | 1 |
| 49288-0473-5 | Sole | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ENGLISH SOLE | ACTIVE INGREDIENT | 00CR8124AS | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
| ENGLISH SOLE | ACTIVE MOIETY | 00CR8124AS | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49288-0473 | SOLE INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | Legacy NDC, 5 package rows | 20091215_5a47186d-964b-42e2-bc55-c18cd6fbc08f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 49288-0473-1 | 49288047301 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | Historical |
| 49288-0473-2 | 49288047302 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |
| 49288-0473-3 | 49288047303 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 49288-0473-4 | 49288047304 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 49288-0473-5 | 49288047305 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |