Mirabegron
- Product NDC
- 67184-0571
- 11-digit product format
- 671840571
- Labeler code
- 67184
- Product ID
- 67184-0571_b4283ace-4312-4cab-97c2-0722339d75b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA217989
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirabegron
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRABEGRON | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MVR3JL3B2V |
| Rxcui | 1300791, 1300801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67184-0571-1 | Mirabegron | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 67184-0571-2 | Mirabegron | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0571-1 | 67184057101 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0571-1) | 2025-06-30 | No | No | Current |
| 67184-0571-2 | 67184057102 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0571-2) | 2025-06-30 | No | No | Current |