Prescription drug · NDA
Myrbetriq (mirabegron) NDC 0469-5020
Mirabegron 8 mg/mL · Granule, For suspension, Extended release · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-5020-99 | 00469502099 | 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLEMarketed from Mar 25, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Myrbetriq
- Generic name (nonproprietary)
- mirabegron
- Active ingredients
- Mirabegron — 8 mg/mL
- Dosage form
- Granule, For suspension, Extended release
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213801
- 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 0469-5020_fe8998d8-cf08-4e07-b966-33e8de20abf1SPL ID fe8998d8-cf08-4e07-b966-33e8de20abf1SPL set ID ba9e9e15-e666-4c56-9271-2e24739cfa2dRxCUI 1300791, 1300797, 1300801, 1300803, 2541233, 2541237UNII 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
N400469502099followed by a unit qualifier and the quantityPackage 00469-5020-99. 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)
MYRBETRIQ is a 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, either alone or in combination with the muscarinic antagonist solifenacin succinate. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) MYRBETRIQ Monotherapy MYRBETRIQ ® is indicated for the treatment of OAB in adult patients with symptoms of urge urina…
Excerpt only. Read the full label for complete information.