Prescription drug · NDA
Remeronsoltab (mirtazapine) NDC 78206-159
Mirtazapine 45 mg/1 · Tablet, Orally disintegrating · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-159-01 | 78206015901 | 5 BLISTER PACK in 1 BOX (78206-159-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-159-99)Marketed from Jun 1, 2021 |
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)
- Remeronsoltab
- Generic name (nonproprietary)
- mirtazapine
- Active ingredients
- Mirtazapine — 45 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021208
- Marketing start
- Listing expires
- Identifiers
- Product ID 78206-159_8b121c7c-9bcd-4504-b789-3f551a0fe514SPL ID 8b121c7c-9bcd-4504-b789-3f551a0fe514SPL set ID 98ad1917-a094-44f5-a28f-a64a8cfcd887RxCUI 211322, 211323, 283406, 283407, 283485, 311725, 314111, 752869, 752870, 752871UNII A051Q2099QUPC 0378206161017, 0378206160010
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
N478206015901followed by a unit qualifier and the quantityPackage 78206-0159-01. 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)
REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . REMERON/REMERONSolTab 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 NDA 021208
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 |
|---|---|---|---|---|
| Remeronsoltabmirtazapine | Mirtazapine 15 mg/1 | Tablet, Orally disintegratingOral | Organon LLC | 78206-156 |
| Remeronsoltabmirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Organon LLC | 78206-158 |