NDC 0517-0125
PROVAYBLUE
Methylene Blue
PROVAYBLUE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Methylene Blue.
| Product ID | 0517-0125_5962f6c3-13e2-4597-abd6-4ff4ac8ed227 |
| NDC | 0517-0125 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PROVAYBLUE |
| Generic Name | Methylene Blue |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-04-08 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204630 |
| Labeler Name | American Regent, Inc. |
| Substance Name | METHYLENE BLUE |
| Active Ingredient Strength | 5 mg/mL |
| Pharm Classes | Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0517-0125-05
5 AMPULE in 1 CARTON (0517-0125-05) > 2 mL in 1 AMPULE (0517-0125-01)
| Marketing Start Date | 2020-04-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0517-0125-01 [00517012501]
PROVAYBLUE INJECTION
| Marketing Category | NDA |
| Application Number | NDA204630 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-18 |
NDC 0517-0125-05 [00517012505]
PROVAYBLUE INJECTION
| Marketing Category | NDA |
| Application Number | NDA204630 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-18 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| METHYLENE BLUE | 5 mg/mL |
OpenFDA Data
| SPL SET ID: | 4f6848e5-35ed-4046-b13c-3032b5ba3232 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Oxidation-Reduction Activity [MoA]
- Oxidation-Reduction Agent [EPC]
- Oxidation-Reduction Activity [MoA]
- Oxidation-Reduction Agent [EPC]
NDC Crossover Matching brand name "PROVAYBLUE" or generic name "Methylene Blue"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0517-0125 | PROVAYBLUE | methylene blue |
| 0517-0371 | PROVAYBLUE | methylene blue |
| 0517-0374 | PROVAYBLUE | methylene blue |
| 0517-0381 | PROVAYBLUE | methylene blue |
| 82454-0125 | PROVAYBLUE | methylene blue |
| 82454-0371 | PROVAYBLUE | methylene blue |
| 82454-0374 | PROVAYBLUE | methylene blue |
| 82454-0381 | PROVAYBLUE | methylene blue |
| 17478-504 | Methylene Blue | Methylene Blue |
| 52584-504 | Methylene Blue | Methylene Blue |
| 54288-147 | Methylene Blue | Methylene Blue |
Trademark Results [PROVAYBLUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROVAYBLUE 86930634 5242388 Live/Registered |
PROVEPHARM LIFE SOLUTIONS 2016-03-07 |
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