Prescription drug · ANDA
Mirabegron NDC 73190-116
Mirabegron 50 mg/1 · Tablet, Film coated, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-116-30 | 7319001163073190011630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73190-116-30)Marketed from Oct 30, 2026 | |
| 73190-116-90 | 7319001169073190011690 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73190-116-90)Marketed from Oct 30, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Mirabegron
- Generic name (nonproprietary)
- mirabegron
- Active ingredients
- Mirabegron — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AvKARENDC labeler code 73190
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218543
- 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 73190-116_5f102149-ad28-4956-e063-6294a90ac6adSPL ID 5f102149-ad28-4956-e063-6294a90ac6adSPL set ID 5f102149-ad27-4956-e063-6294a90ac6adUNII MVR3JL3B2VUPC 0373190116302
- 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
N473190011630followed by a unit qualifier and the quantityPackage 73190-0116-30. 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 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. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Monotherapy Mirabegron is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron Mirabegron is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg o…
Excerpt only. Read the full label for complete information.
About NDC 73190-116
- What is NDC 73190-116?
- 73190-116 is the product NDC for Mirabegron, Mirabegron 50 mg/1 tablet, film coated, extended release, listed with the FDA by AvKARE. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mirabegron.
- What is the active ingredient?
- Mirabegron.
- Who is the labeler?
- AvKARE, NDC labeler code 73190. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mirabegron?
- 18 other product NDCs are listed under this name. See all Mirabegron NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mirabegron products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | AvKARE | 73190-115 | 73190-0115-3073190-0115-90 |
| Mirabegron | Mirabegron 8 mg/mL | For suspension, Extended releaseOral | Ascend Laboratories, LLC | 67877-890 | 67877-0890-88 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4665 | 70518-4665-00 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4631 | 70518-4631-00 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2860 | 69238-2860-0169238-2860-02 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2861 | 69238-2861-0169238-2861-02 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Qilu Pharmaceutical Co., Ltd. | 67184-0571 | 67184-0571-0167184-0571-02 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4304 | 70518-4304-00 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2808 | 71335-2808-01 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2810 | 71335-2810-01 |
Other NDCs under ANDA 218543
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 | Amneal Pharmaceuticals NY LLC | 69238-2860 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2861 |