NDC 49288-0317
Melaleuca
Melaleuca
Melaleuca is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Melaleuca Quinquenervia Pollen.
| Product ID | 49288-0317_13c9eea1-38b5-472b-b735-a814ca886718 |
| NDC | 49288-0317 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Melaleuca |
| Generic Name | Melaleuca |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRADERMAL; SUBCUTANEOUS |
| Marketing Start Date | 1974-03-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102223 |
| Labeler Name | Antigen Laboratories, Inc. |
| Substance Name | MELALEUCA QUINQUENERVIA POLLEN |
| Active Ingredient Strength | 0 g/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 49288-0317-1
2 mL in 1 VIAL, MULTI-DOSE (49288-0317-1)
| Marketing Start Date | 1974-03-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 49288-0317-2 [49288031702]
Melaleuca INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0317-4 [49288031704]
Melaleuca INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0317-5 [49288031705]
Melaleuca INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0317-3 [49288031703]
Melaleuca INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
NDC 49288-0317-1 [49288031701]
Melaleuca INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102223 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1974-03-23 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MELALEUCA QUINQUENERVIA POLLEN | .05 g/mL |
OpenFDA Data
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 "Melaleuca" or generic name "Melaleuca"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0268-1277 | MELALEUCA | MELALEUCA QUINQUENERVIA |
| 49288-0317 | Melaleuca | Melaleuca |
Trademark Results [Melaleuca]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MELALEUCA 98845862 not registered Live/Pending |
RnC Limited 2024-11-12 |
 MELALEUCA 97728427 not registered Live/Pending |
RnC Limited 2022-12-22 |
 MELALEUCA 74186540 1917518 Live/Registered |
MELALEUCA INC 1991-07-19 |
 MELALEUCA 74186539 1917517 Live/Registered |
Melaleuca, Inc. 1991-07-19 |
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