Treatment Set TS345381
- Product NDC
- 49288-0847
- 11-digit product format
- 492880847
- Labeler code
- 49288
- Product ID
- 49288-0847_9a8e59e8-156a-4999-a000-b68054b405d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Treatment Set TS345381
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102223
- Marketing category
- BLA
- Marketing start
- 1986-10-31
- Marketing end
- 0000-00-00
- Substance
- ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM
- Active strength
- 0 g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/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],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],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],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49288-0847-3 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b95d-f6ea-e053-dbdaa90aa703 | ALLERGENIC EXTRACTS INDIVIDUAL TREATMENT VIAL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49288-0847-3 | Treatment Set TS345381 | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49288-0847 | TREATMENT SET TS344592 INJECTION, SOLUTION TREATMENT SET TS344801 INJECTION, SOLUTION TREATMENT SET TS345048 INJECTION, SOLUTION TREATMENT SET TS345049 INJECTION, SOLUTION TREATMENT SET TS345050 INJECTION, SOLUTION TREATMENT SET TS345268 INJECTION, SOLUTION TREATMENT SET TS345302 INJECTION, SOLUTION TREATMENT SET TS345303 INJECTION, SOLUTION TREATMENT SET TS345380 INJECTION, SOLUTION TREATMENT SET TS345381 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 1 | Legacy NDC, 1 package rows | 20120323_354ef6d9-c531-4958-bc94-00e52569c0e1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1248595 | dog hair extract 20 MG/mL / European house dust mite extract 2000 UNT/mL Injectable Solution | PSN | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
| 1248605 | giant ragweed pollen extract 10 MG/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution | PSN | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
| 1248595 | dog hair extract 20 MG/ML / European house dust mite allergenic extract 2000 UNT/ML Injectable Solution | SCD | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
| 1248605 | giant ragweed pollen extract 10 MG/ML / short ragweed pollen extract 20000 UNT/ML Injectable Solution | SCD | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
| 1248605 | Ambrosia trifida pollen extract 10 MG/ML / Ambrosia artemisiifolia pollen extract 20,000 UNT/ML Injectable Solution | SY | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
| 1248595 | Canis lupus familiaris 20 MG/ML / Dermatophagoides pteronyssinus 2000 UNT/ML Injectable Solution | SY | 354ef6d9-c531-4958-bc94-00e52569c0e1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 49288-0847-3 | 49288084703 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |