10 TREE MIX
- Product NDC
- 0268-8000
- 11-digit product format
- 002688000
- Labeler code
- 0268
- Product ID
- 0268-8000_78f45cdb-937a-4516-b8b8-3e5095a98154
- Type
- NON-STANDARDIZED ALLERGENIC
- Nonproprietary name
- ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN and ULMUS AMERICANA POLLEN
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103753
- Marketing category
- BLA
- Marketing start
- 1998-02-23
- Substance
- ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; BLACK WALNUT; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN
- Active strength
- .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Nut Proteins [EXT], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 10 TREE MIX
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACER NEGUNDO POLLEN | .05 g/mL |
| BETULA NIGRA POLLEN | .05 g/mL |
| BLACK WALNUT | .05 g/mL |
| CARYA OVATA POLLEN | .05 g/mL |
| FRAXINUS AMERICANA POLLEN | .05 g/mL |
| PLATANUS OCCIDENTALIS POLLEN | .05 g/mL |
| POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN | .05 g/mL |
| QUERCUS RUBRA POLLEN | .05 g/mL |
| SALIX NIGRA POLLEN | .05 g/mL |
| ULMUS AMERICANA POLLEN | .05 g/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0268-8000-10 | 10 TREE MIX | 10.5 mL in 1 VIAL | INJECTION, SOLUTION | 10.5 | 8 | |
| 0268-8000-50 | 10 TREE MIX | 53 mL in 1 VIAL | INJECTION, SOLUTION | 53 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0268-8000 | MIXED ASPERGILLUS (ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER) INJECTION, SOLUTION MIXED MOLDS (ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION MIXED PENICILLIUM (PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM) INJECTION, SOLUTION 10 TREE MIX (ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA POLLEN AND ULMUS AMERICANA POLLEN) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION BIRCH MIX (BETULA NIGRA, BETULA POPULIFOLIA) INJECTION, SOLUTION [ALK-ABELLO, | 8 | Current NDC, Legacy NDC, 2 package rows | 20230602_1f7f1612-c7b2-4948-b35b-fcaa92de8989.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1927658 | gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution | PSN | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 966954 | Penicillium chrysogenum var. chrysogenum allergenic extract 20,000 UNT/mL Injectable Solution | PSN | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 1927658 | gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution | SCD | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 966954 | Penicillium chrysogenum var. chrysogenum allergenic extract 20000 UNT/ML Injectable Solution | SCD | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 1927658 | Betula nigra pollen extract 0.05 GM/ML / Betula populifolia pollen extract 0.05 GM/ML Injectable Solution | SY | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 1927658 | Betula nigra pollen extract 50 MG/ML / Betula populifolia pollen extract 50 MG/ML Injectable Solution | SY | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 966954 | Penicillium chrysogenum var. chrysogenum extract 20,000 UNT/ML Injectable Solution | SY | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
| 966954 | Penicillium notatum allergenic extract 20,000 UNT/ML Injectable Solution | SY | 1f7f1612-c7b2-4948-b35b-fcaa92de8989 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0268-8000-10 | 00268800010 | 10.5 mL in 1 VIAL (0268-8000-10) | 10.5 ml | 1998-02-23 | 0000-00-00 | No | No | Current |
| 0268-8000-50 | 00268800050 | 53 mL in 1 VIAL (0268-8000-50) | 53 ml | 1998-02-23 | 0000-00-00 | No | No | Current |