Myrbetriq
- Product NDC
- 70518-3158
- 11-digit product format
- 705183158
- Labeler code
- 70518
- Product ID
- 70518-3158_ee4f763d-bd7c-a027-e053-2a95a90a280b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA202611
- Marketing category
- NDA
- Marketing start
- 2021-07-15
- Marketing end
- 0000-00-00
- Substance
- MIRABEGRON
- Active strength
- 25 mg/1
- Pharmacologic classes
- Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3158-0 | 70518315800 | 30 POUCH in 1 BOX (70518-3158-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-3158-1) | 30 pouch | 2021-07-15 | 0000-00-00 | No | No | Current |
| 70518-3158-2 | 70518315802 | 30 POUCH in 1 BOX (70518-3158-2) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-3158-3) | 30 pouch | 2022-01-31 | 0000-00-00 | No | No | Current |