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NDC 70518-2435-03 Myrbetriq 50 mg/1 Details
Myrbetriq 50 mg/1
Myrbetriq is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is MIRABEGRON.
MedlinePlus Drug Summary
Mirabegron is used alone or in combination with solifenacin (Vesicare) to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. It is also used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 3 years of age and older. Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.
Related Packages: 70518-2435-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mirabegron
Product Information
| NDC | 70518-2435 |
|---|---|
| Product ID | 70518-2435_0412be58-65e6-bff3-e063-6394a90a6cd9 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Myrbetriq |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mirabegron |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | MIRABEGRON |
| Labeler Name | REMEDYREPACK INC. |
| Pharmaceutical Class | Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA202611 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70518-2435-03 (70518243503)
| NDC Package Code | 70518-2435-3 |
|---|---|
| Billing NDC | 70518243503 |
| Package | 30 POUCH in 1 BOX (70518-2435-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-4) |
| Marketing Start Date | 2022-05-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |