Mirabegron
- Product NDC
- 69238-2861
- 11-digit product format
- 692382861
- Labeler code
- 69238
- Product ID
- 69238-2861_0bfa52f0-d4b2-4fb1-b3ee-da4cba2b18fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirabegron
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA218543
- Marketing category
- ANDA
- Marketing start
- 2026-04-19
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirabegron
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRABEGRON | 50 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 |
|---|
| 69238-2861-1 | Mirabegron | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 4 |
| 69238-2861-2 | Mirabegron | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-2861-1 | 69238286101 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-1) | 2026-04-19 | No | No | Historical |
| 69238-2861-2 | 69238286102 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2861-2) | 2026-04-19 | No | No | Historical |