Myrbetriq
- Product NDC
- 70518-2435
- 11-digit product format
- 705182435
- Labeler code
- 70518
- Product ID
- 70518-2435_ea71feb1-4def-1170-e053-2a95a90a62e5
- 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
- 2019-11-19
- Marketing end
- 0000-00-00
- Substance
- MIRABEGRON
- Active strength
- 50 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2435 | MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] | 9 | Legacy NDC | 20250316_f499d877-7699-424d-bd74-7c12d1bad129.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2435-0 | 70518243500 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2435-0) | | 2019-11-19 | 0000-00-00 | No | No | Current |
| 70518-2435-1 | 70518243501 | 30 POUCH in 1 BOX (70518-2435-1) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-2) | 30 pouch | 2021-07-14 | 0000-00-00 | No | No | Current |
| 70518-2435-3 | 70518243503 | 30 POUCH in 1 BOX (70518-2435-3) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-4) | 30 pouch | 2022-05-03 | 0000-00-00 | No | No | Current |