Mirabegron
- Product NDC
- 70518-4631
- 11-digit product format
- 705184631
- Labeler code
- 70518
- Product ID
- 70518-4631_5076a7de-d811-a873-e063-6294a90a5c37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirabegron
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209488
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- 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
- 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 | 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 |
|---|
| 70518-4631-0 | Mirabegron | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | | 1 |
| 70518-4631-1 | Mirabegron | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4631-0 | 70518463100 | 50 POUCH in 1 BOX (70518-4631-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4631-1) | 50 pouch | 2026-04-24 | No | No | Historical |
| 70518-4631-1 | 70518463101 | 1 in 1 POUCH | | | | | Historical |