Prescription drug · ANDA
Mirtazapine NDC 57664-510
Mirtazapine 7.5 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-510-83 | 57664051083 | 30 TABLET in 1 BOTTLE (57664-510-83)Marketed from Apr 22, 2004 |
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)
- Mirtazapine
- Generic name (nonproprietary)
- mirtazapine
- Active ingredients
- Mirtazapine — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076541
- Marketing start
- Listing expires
- Identifiers
- Product ID 57664-510_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6SPL ID f5e842da-4922-4f1d-b2e0-a4c0be71e2a6SPL set ID f23631be-c7ae-46e9-b771-a70be17bc9f0RxCUI 311725, 311726, 314111, 476809UNII A051Q2099QUPC 0357664500835
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
N457664051083followed by a unit qualifier and the quantityPackage 57664-0510-83. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076541
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 |
|---|---|---|---|---|
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-499 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-713 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-500 |
| Mirtazapine | Mirtazapine 45 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-501 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0441 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0286 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4548 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2963 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2366 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | TabletOral | AvKARE | 42291-494 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2367 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2368 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1639 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1640 |