Prescription drug · ANDA
Mirabegron NDC 70518-4631
Mirabegron 25 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4631-0 | 70518463100 | 50 POUCH in 1 BOX (70518-4631-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4631-1)Marketed from Apr 24, 2026 |
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 — 25 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209488
- 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 70518-4631_5076a7de-d811-a873-e063-6294a90a5c37SPL ID 5076a7de-d811-a873-e063-6294a90a5c37SPL set ID b71b939e-8cb1-492c-8311-28f75dc4c682RxCUI 1300791UNII 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
N470518463100followed by a unit qualifier and the quantityPackage 70518-4631-00. 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 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 extended-release tablets are 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 extended-release tablets are indicated for the treatment of ND…
Excerpt only. Read the full label for complete information.
About NDC 70518-4631
- What is NDC 70518-4631?
- 70518-4631 is the product NDC for Mirabegron, Mirabegron 25 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 16 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 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, 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 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-152 | 68180-0152-0668180-0152-09 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2807 | 71335-2807-01 |
Other NDCs under ANDA 209488
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, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1159 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1160 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4304 |
| Mirabegron | Mirabegron 25 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1752 |
| Mirabegron | Mirabegron 50 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1753 |