Myrbetriq
- Product NDC
- 55154-8712
- 11-digit product format
- 551548712
- Labeler code
- 55154
- Product ID
- 55154-8712_eaa551c0-5c11-45b4-9f9b-3533810c065b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- NDA202611
- Marketing category
- NDA
- Marketing start
- 2012-06-28
- 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
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8712 | MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC] | 6 | Legacy NDC | 20241003_aaaf3bea-1b21-4edf-9300-b7159ea9ede8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-8712-8 | 55154871208 | 960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8712-8) | 2012-06-28 | 0000-00-00 | No | No | Current |