NDC 49502-806
YUPELRI
Revefenacin
YUPELRI is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Revefenacin.
| Product ID | 49502-806_10a82af1-5439-42be-b133-7ac409784ea9 |
| NDC | 49502-806 |
| Product Type | Human Prescription Drug |
| Proprietary Name | YUPELRI |
| Generic Name | Revefenacin |
| Dosage Form | Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2018-12-03 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210598 |
| Labeler Name | Mylan Specialty L.P. |
| Substance Name | REVEFENACIN |
| Active Ingredient Strength | 175 ug/3mL |
| Pharm Classes | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 49502-806-87
7 POUCH in 1 CARTON (49502-806-87) > 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) > 3 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2019-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
NDC SPL Data Element Entries
NDC 49502-806-87 [49502080687]
YUPELRI SOLUTION
| Marketing Category | NDA |
| Application Number | NDA210598 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-01-01 |
NDC 49502-806-93 [49502080693]
YUPELRI SOLUTION
| Marketing Category | NDA |
| Application Number | NDA210598 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-12-03 |
NDC 49502-806-32 [49502080632]
YUPELRI SOLUTION
| Marketing Category | NDA |
| Application Number | NDA210598 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-12-03 |
NDC 49502-806-33 [49502080633]
YUPELRI SOLUTION
| Marketing Category | NDA |
| Application Number | NDA210598 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-03 |
NDC 49502-806-77 [49502080677]
YUPELRI SOLUTION
| Marketing Category | NDA |
| Application Number | NDA210598 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-22 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| REVEFENACIN | 175 ug/3mL |
OpenFDA Data
| SPL SET ID: | 6dfebf04-7c90-436a-9b16-750d3c1ee0a6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Trademark Results [YUPELRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 YUPELRI 87751266 not registered Live/Pending |
Mylan Specialty L.P. 2018-01-11 |
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