Prescription drug · ANDA
Mirtazapine NDC 76483-112
Mirtazapine 45 mg/1 · Tablet, Orally disintegrating · Oral · SQUARE PHARMACEUTICALS LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-112-00 | 76483011200 | 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-112-00)Marketed from Nov 15, 2022 |
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 — 45 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205798
- Marketing start
- Listing expires
- Identifiers
- Product ID 76483-112_d6b98cf3-2e20-47c1-bb31-e8dd31f67cdfSPL ID d6b98cf3-2e20-47c1-bb31-e8dd31f67cdfSPL set ID 83093852-d212-408e-98fd-33f4603a9d65RxCUI 283406, 283407, 283485UNII 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
N476483011200followed by a unit qualifier and the quantityPackage 76483-0112-00. 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 .
Other NDCs under ANDA 205798
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, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-110 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-111 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-105 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-103 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-104 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2471 |