Prescription drug · ANDA
Mirtazapine NDC 63739-098
Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · McKesson Corporation dba SKY Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63739-098-10 | 63739009810 | 10 BLISTER PACK in 1 BOX (63739-098-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 15, 2019 |
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 — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
- Marketing start
- Marketing end
- Identifiers
- Product ID 63739-098_2bb25f3c-7005-6710-e063-6294a90a022cSPL ID 2bb25f3c-7005-6710-e063-6294a90a022cSPL set ID 40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5RxCUI 311725, 314111UNII A051Q2099Q
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
N463739009810followed by a unit qualifier and the quantityPackage 63739-0098-10. 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 is 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 077666
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 | Tablet, Film coatedOral | Proficient Rx LP | 63187-206 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-952 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Direct_Rx | 61919-153 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-378 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | McKesson Corporation dba SKY Packaging | 63739-099 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1058 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1590 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-471 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6519 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0248 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0247 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0249 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-554 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-717 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7297 |