Prescription drug · ANDA
Mirabegron NDC 67877-890
Mirabegron 8 mg/mL · For suspension, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-890-88 | 67877089088 | 1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLEMarketed from Jun 15, 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 — 8 mg/mL
- Dosage form
- For suspension, Extended release
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219323
- 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 67877-890_bea3fc38-dab4-4a11-b7a1-911b302f6504SPL ID bea3fc38-dab4-4a11-b7a1-911b302f6504SPL set ID 1c9022af-4841-4f3f-9737-1c5eef58e86bRxCUI 2541233UNII 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
N467877089088followed by a unit qualifier and the quantityPackage 67877-0890-88. 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 for extended-release oral suspension is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron for Extended-Release Oral Suspension Mirabegron for extended-release oral suspension is indicated for the treatment of NDO in pediatric patients aged 3 years and older.
Excerpt only. Read the full label for complete information.
About NDC 67877-890
- What is NDC 67877-890?
- 67877-890 is the product NDC for Mirabegron, Mirabegron 8 mg/mL for suspension, extended release, listed with the FDA by Ascend Laboratories, LLC. 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 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 | Lupin Pharmaceuticals, Inc. | 68180-152 | 68180-0152-0668180-0152-09 |
| 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 25 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-151 | 68180-0151-0668180-0151-09 |