Prescription drug · ANDA
Mirtazapine NDC 72162-1640
Mirtazapine 30 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1640-0 | 72162164000 | 1000 TABLET in 1 BOTTLE (72162-1640-0)Marketed from Jul 16, 2024 | |
| 72162-1640-2 | 72162164002 | 45 TABLET in 1 BOTTLE (72162-1640-2)Marketed from Aug 28, 2023 | |
| 72162-1640-3 | 72162164003 | 30 TABLET in 1 BOTTLE (72162-1640-3)Marketed from Aug 28, 2023 | |
| 72162-1640-5 | 72162164005 | 500 TABLET in 1 BOTTLE (72162-1640-5)Marketed from Aug 28, 2023 |
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)
- Mirtazapine
- Generic name (nonproprietary)
- mirtazapine
- Active ingredients
- Mirtazapine — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076541
- Marketing start
- Listing expires
- Identifiers
- Product ID 72162-1640_ec83d85a-e001-4696-8049-cb3eaa90bed8SPL ID ec83d85a-e001-4696-8049-cb3eaa90bed8SPL set ID ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5RxCUI 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
N472162164000followed by a unit qualifier and the quantityPackage 72162-1640-00. 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 . 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 7.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-510 |
| 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 |