MIRABEGRON
- Product NDC
- 71335-2807
- 11-digit product format
- 713352807
- Labeler code
- 71335
- Product ID
- 71335-2807_fe552468-ccc5-4362-b462-10fb7f10cf18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209485
- Marketing category
- ANDA
- Marketing start
- 2024-04-19
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2807-1 | MIRABEGRON | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 100 |
| 71335-2807-1 | MIRABEGRON | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2807-1 | 71335280701 | 1 BOTTLE in 1 CARTON (71335-2807-1) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2025-09-26 | No | No | Historical |