Mold Mix B
- Product NDC
- 0268-8112
- 11-digit product format
- 002688112
- Labeler code
- 0268
- Product ID
- 0268-8112_93fe3f8e-51cb-41f4-9b1c-f7c9733b24fb
- Type
- NON-STANDARDIZED ALLERGENIC
- Nonproprietary name
- EPICOCCUM NIGRUM, GIBBERELLA ZEAE and MUCOR PLUMBEUS
- Dosage form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS; SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103753
- Marketing category
- BLA
- Marketing start
- 1965-01-01
- Substance
- EPICOCCUM NIGRUM; GIBBERELLA ZEAE; MUCOR PLUMBEUS
- Active strength
- .05; .05; .05 g/mL; g/mL; g/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal 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
- Mold Mix B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPICOCCUM NIGRUM | .05 g/mL |
| GIBBERELLA ZEAE | .05 g/mL |
| MUCOR PLUMBEUS | .05 g/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0268-8112-05 | Mold Mix B | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 4 |
| 0268-8112-10 | Mold Mix B | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 3 |
| 0268-8112-50 | Mold Mix B | 53 mL in 1 VIAL | INJECTION, SOLUTION | 53 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0268-8112 | MOLD MIX A (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, CLADOSPORIUM CLADOSPORIOIDES AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX B (EPICOCCUM NIGRUM, GIBBERELLA ZEAE AND MUCOR PLUMBEUS) INJECTION, SOLUTION MOLD MIX C (BOTRYTIS CINEREA, CANDIDA ALBICANS, RHODOTORULA MUCILAGINOSA AND TRICHOPHYTON MENTAGROPHYTES) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230526_3dc61efa-bda7-4f40-83d0-dc63a0b1a2c2.zip |
| 0268-8112 | MOLD MIX A (ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, CLADOSPORIUM CLADOSPORIOIDES AND PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX B (EPICOCCUM NIGRUM, GIBBERELLA ZEAE AND MUCOR PLUMBEUS) INJECTION, SOLUTION MOLD MIX C (BOTRYTIS CINEREA, CANDIDA ALBICANS, RHODOTORULA MUCILAGINOSA AND TRICHOPHYTON MENTAGROPHYTES) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230526_5b96f92d-8183-4d11-aca3-4f0bcefb22a9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0268-8112-05 | 00268811205 | 5 mL in 1 VIAL (0268-8112-05) | 5 ml | 1965-01-01 | 0000-00-00 | No | No | Current |
| 0268-8112-10 | 00268811210 | 10 mL in 1 VIAL (0268-8112-10) | 10 ml | 1965-01-01 | 0000-00-00 | No | No | Current |
| 0268-8112-50 | 00268811250 | 53 mL in 1 VIAL (0268-8112-50) | 53 ml | 1965-01-01 | 0000-00-00 | No | No | Current |