Prescription drug · ANDA
Mirabegron NDC 71335-2808
Mirabegron 50 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2808-1 | 71335280801 | 1 BOTTLE in 1 CARTON (71335-2808-1) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 26, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mirabegron
- Generic name (nonproprietary)
- mirabegron
- Active ingredients
- Mirabegron — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209485
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta3-Agonists (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2808_6bbfdbeb-02d5-4be9-b6b3-b6fd9c97e1c9SPL ID 6bbfdbeb-02d5-4be9-b6b3-b6fd9c97e1c9SPL set ID 00826723-d25e-498a-b8d4-d17e5c14dda5RxCUI 1300801UNII MVR3JL3B2V
- Pharmacologic class
- beta3-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335280801followed by a unit qualifier and the quantityPackage 71335-2808-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. Pediatric use information is approved for Astellas Pharma Global Development, Inc.'s MYRBETRIQ (mirabegron extended-release tablets). However, due to Astellas Pharma Global Development, Inc.'s marketing exclusivity rights, …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209485
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2809 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2807 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2810 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4665 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-152 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-151 |