MOLD MIX 1
- Product NDC
- 0268-8064
- 11-digit product format
- 002688064
- Labeler code
- 0268
- Product ID
- 0268-8064_25c99df0-1f9c-45e1-950b-88e8cb11ed1d
- Type
- NON-STANDARDIZED ALLERGENIC
- Nonproprietary name
- ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, CLADOSPORIUM SPHAEROSPERMUM, COCHLIOBOLUS SATIVUS and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- ALK-Abello, Inc.
- Application
- BLA103753
- Marketing category
- BLA
- Marketing start
- 1965-01-01
- Marketing end
- 0000-00-00
- Substance
- PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; COCHLIOBOLUS SATIVUS; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM SPHAEROSPERMUM
- Active strength
- 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
- Pharmacologic classes
- Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0268-8064-10 | MOLD MIX 1 | 10.5 mL in 1 VIAL | INJECTION, SOLUTION | 10.5 | 5 | |
| 0268-8064-50 | MOLD MIX 1 | 53 mL in 1 VIAL | INJECTION, SOLUTION | 53 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0268-8064 | MIXED ASPERGILLUS (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER, GALLUS GALLUS FEATHER) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) .......NUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX 2 (AUREOBASIDIUM PULLULANS, CURVULARIA INAEQUALIS, FUSARIUM ROSEUM, MUCOR PLUMBEUS, PHIZOPUS ORYZAE) INJECTION, SOLUTION FAPP MIXTURE (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, GIBBERELLA ZEAE, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PHOMA EXIGUA VAR. EXIGUA) INJECTION, SOLUTION [ALK-ABELLO, INC.] | 5 | Legacy NDC, 2 package rows | 20230525_5f15c12a-8df0-41de-9d59-7de47e5e89ca.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1922788 | giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable Solution | PSN | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922791 | giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable Solution | PSN | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922797 | pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable Solution | PSN | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966954 | Penicillium chrysogenum var. chrysogenum allergenic extract 20,000 UNT/mL Injectable Solution | PSN | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966960 | Penicillium chrysogenum var. chrysogenum allergenic extract 40,000 UNT/mL Injectable Solution | PSN | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922788 | giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable Solution | SCD | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922791 | giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable Solution | SCD | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922797 | pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable Solution | SCD | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966954 | Penicillium chrysogenum var. chrysogenum allergenic extract 20000 UNT/ML Injectable Solution | SCD | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966960 | Penicillium chrysogenum var. chrysogenum allergenic extract 40000 UNT/ML Injectable Solution | SCD | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922788 | Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922788 | Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922791 | Ambrosia artemisiifolia pollen extract 40000 PNU/ML / Ambrosia trifida pollen extract 40000 PNU/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922791 | Ambrosia artemisiifolia pollen extract 40000 UNT/ML / Ambrosia trifida pollen extract 40000 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 1922797 | Carya illinoinensis pollen UNT/ML / Carya ovata pollen extract 100 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966954 | Penicillium chrysogenum var. chrysogenum extract 20,000 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966960 | Penicillium chrysogenum var. chrysogenum extract 40,000 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966954 | Penicillium notatum allergenic extract 20,000 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
| 966960 | Penicillium notatum allergenic extract 40,000 UNT/ML Injectable Solution | SY | 5f15c12a-8df0-41de-9d59-7de47e5e89ca | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0268-8064-10 | 00268806410 | 10.5 mL in 1 VIAL (0268-8064-10) | 10.5 ml | 1965-01-01 | 0000-00-00 | No | No | Current |
| 0268-8064-50 | 00268806450 | 53 mL in 1 VIAL (0268-8064-50) | 53 ml | 1965-01-01 | 0000-00-00 | No | No | Current |