Mirabegron
- Product NDC
- 70710-1159
- 11-digit product format
- 707101159
- Labeler code
- 70710
- Product ID
- 70710-1159_df34c0c9-8528-4fd6-a408-e1d44da0f156
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirabegron
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA209488
- Marketing category
- ANDA
- Marketing start
- 2024-01-23
- 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, 1300801 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1159-1 | Mirabegron | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 70710-1159-3 | Mirabegron | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 70710-1159-9 | Mirabegron | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1159 | MIRABEGRON TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, 3 package rows | 20241013_2e40eb74-3b2a-47f7-bf31-fe27484f9bd2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1159-1 | 70710115901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-1) | 2024-01-23 | No | No | Current |
| 70710-1159-3 | 70710115903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-3) | 2024-01-23 | No | No | Current |
| 70710-1159-9 | 70710115909 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-9) | 2024-01-23 | No | No | Current |