NDC 36987-3127
Dandelion
Dandelion
Dandelion is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Taraxacum Officinale Pollen.
| Product ID | 36987-3127_d152b7aa-b962-4303-9744-c8947edc1d6d |
| NDC | 36987-3127 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dandelion |
| Generic Name | Dandelion |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1972-08-29 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102192 |
| Labeler Name | Nelco Laboratories, Inc. |
| Substance Name | TARAXACUM OFFICINALE POLLEN |
| Active Ingredient Strength | 20000 [PNU]/mL |
| Pharm Classes | Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 36987-3127-4
50 mL in 1 VIAL, MULTI-DOSE (36987-3127-4)
| Marketing Start Date | 1972-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 36987-3127-3 [36987312703]
Dandelion INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-3127-2 [36987312702]
Dandelion INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-3127-1 [36987312701]
Dandelion INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
NDC 36987-3127-4 [36987312704]
Dandelion INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1972-08-29 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TARAXACUM OFFICINALE POLLEN | 20000 [PNU]/mL |
OpenFDA Data
| SPL SET ID: | efc51970-c1a4-45e7-864b-4f0587896459 |
| Manufacturer | |
| UNII |
|
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Non-Standardized Pollen Allergenic Extract [EPC]
- Increased Histamine Release [PE]
- Cell-mediated Immunity [PE]
- Increased IgG Production [PE]
- Pollen [CS]
- Allergens [CS]
NDC Crossover Matching brand name "Dandelion" or generic name "Dandelion"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-7100 | DANDELION | TARAXACUM OFFICINALE POLLEN |
| 22840-1500 | Dandelion | Taraxacum officinale |
| 22840-1501 | Dandelion | Taraxacum officinale |
| 22840-1502 | Dandelion | Taraxacum officinale |
| 22840-1571 | Dandelion | Taraxacum officinale |
| 22840-1572 | Dandelion | Taraxacum officinale |
| 22840-1573 | Dandelion | Taraxacum officinale |
| 22840-5501 | Dandelion | Taraxacum officinale |
| 36987-3125 | Dandelion | Dandelion |
| 36987-3126 | Dandelion | Dandelion |
| 36987-3127 | Dandelion | Dandelion |
| 36987-3128 | Dandelion | Dandelion |
| 36987-3129 | Dandelion | Dandelion |
| 36987-3130 | Dandelion | Dandelion |
| 36987-3131 | Dandelion | Dandelion |
| 36987-3132 | Dandelion | Dandelion |
| 49288-0169 | Dandelion | Dandelion |
Trademark Results [Dandelion]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.