Prescription drug · ANDA
mirtazapine NDC 31722-408
Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-408-05 | 31722040805 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-408-05)Marketed from Oct 2, 2025 | |
| 31722-408-10 | 31722040810 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-408-10)Marketed from Oct 2, 2025 | |
| 31722-408-30 | 31722040830 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-408-30)Marketed from Oct 2, 2025 |
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
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219721
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-408_4e8e5591-9b05-8885-e063-6394a90a02e8SPL ID 4e8e5591-9b05-8885-e063-6394a90a02e8SPL set ID b4b9b66e-87a1-4dbb-9eaf-71221bcb2265RxCUI 311725, 311726, 314111, 476809UNII A051Q2099QUPC 0331722407304, 0331722408301, 0331722410304, 0331722409308
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
N431722040805followed by a unit qualifier and the quantityPackage 31722-0408-05. 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 219721
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 45 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-410 |
| mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-407 |
| mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-409 |
| mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-369 |
| mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-368 |
| mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-370 |
| mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-371 |
| mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8019 |