Prescription drug · ANDA
Mirtazapine NDC 72578-104
Mirtazapine 30 mg/1 · Tablet, Orally disintegrating · Oral · Viona Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-104-84 | 72578010484 | 5 BLISTER PACK in 1 CARTON (72578-104-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-104-69)Marketed from Aug 7, 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 — 30 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205798
- Marketing start
- Listing expires
- Identifiers
- Product ID 72578-104_9ad8f423-a877-4069-8a11-92e1f934974aSPL ID 9ad8f423-a877-4069-8a11-92e1f934974aSPL set ID ed491abe-9412-428b-8e24-57242862c99aRxCUI 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
N472578010484followed by a unit qualifier and the quantityPackage 72578-0104-84. 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 orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Mirtazapine orally disintegrating 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 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 | SQUARE PHARMACEUTICALS LIMITED | 76483-112 |
| 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 | Bryant Ranch Prepack | 71335-2471 |