Prescription drug · NDA
Myrbetriq (Mirabegron) NDC 0469-2601
Mirabegron 25 mg/1 · Tablet, Film coated, Extended release · Oral · Astellas Pharma US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0469-2601-07 | 0046926010700469260107 | 4 CARTON in 1 TRAY (0469-2601-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 28, 2012 · Sample package | |
| 0469-2601-30 | 0046926013000469260130 | 1 BOTTLE in 1 CARTON (0469-2601-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jun 28, 2012 | |
| 0469-2601-90 | 0046926019000469260190 | 1 BOTTLE in 1 CARTON (0469-2601-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jun 28, 2012 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Astellas Pharma US, Inc.NDC labeler code 0469
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202611
- 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 0469-2601_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
N400469260107followed by a unit qualifier and the quantityPackage 00469-2601-07. 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.
About NDC 0469-2601
- What is NDC 0469-2601?
- 0469-2601 is the product NDC for Myrbetriq (mirabegron), Mirabegron 25 mg/1 tablet, film coated, extended release, listed with the FDA by Astellas Pharma US, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Myrbetriq (Mirabegron).
- What is the active ingredient?
- Mirabegron.
- Who is the labeler?
- Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Myrbetriq?
- 2 other product NDCs are listed under this name. See all Myrbetriq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Myrbetriq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Myrbetriqmirabegron | Mirabegron 8 mg/mL | Granule, For suspension, Extended releaseOral | Astellas Pharma US, Inc. | 0469-5020 | 00469-5020-99 |
| Myrbetriqmirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Astellas Pharma US, Inc. | 0469-2602 | 00469-2602-0700469-2602-3000469-2602-90 |
Other NDCs under NDA 202611
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 |
|---|---|---|---|---|
| Myrbetriqmirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Astellas Pharma US, Inc. | 0469-2602 |