MIRABEGRON
- Product NDC
- 68180-152
- 11-digit product format
- 681800152
- Labeler code
- 68180
- Product ID
- 68180-152_b26f08e4-dfe4-4a0f-b6b5-e9abb495e415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA209485
- Marketing category
- ANDA
- Marketing start
- 2024-09-03
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| MVR3JL3B2V | MIRABEGRON | 223673-61-8 | MIRABEGRON |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-152-06 | 68180015206 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-06) | 2024-09-03 | No | No | Historical |
| 68180-152-09 | 68180015209 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-152-09) | 2024-09-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MIRABEGRON | REMEDYREPACK INC. | 2026-05-22 | HUMAN PRESCRIPTION DRUG LABEL | 1 |
| MIRABEGRON | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-12-24 | HUMAN PRESCRIPTION DRUG LABEL | 19 |
| MIRABEGRON | Bryant Ranch Prepack | 2025-09-26 | HUMAN PRESCRIPTION DRUG LABEL | 100 |
| MIRABEGRON | Bryant Ranch Prepack | 2025-09-26 | HUMAN PRESCRIPTION DRUG LABEL | 100 |