Mirabegron
- Product NDC
- 70518-4304
- 11-digit product format
- 705184304
- Labeler code
- 70518
- Product ID
- 70518-4304_402d6915-bb65-7f50-e063-6394a90a2e46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirabegron
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209488
- Marketing category
- ANDA
- Marketing start
- 2025-03-07
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirabegron
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRABEGRON | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MVR3JL3B2V |
| Rxcui | 1300801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4304-0 | Mirabegron | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4304 | MIRABEGRON TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 2 | Current NDC, 1 package rows | 20250309_5f7a1758-8691-4e53-96d6-a01626ee8140.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4304-0 | 70518430400 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0) | 2025-03-07 | No | No | Historical |