Prescription drug · NDA
Remeron (Mirtazapine) NDC 78206-161
Mirtazapine 30 mg/1 · Tablet, Film coated · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-161-01 | 7820601610178206016101 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01)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)
- Remeron
- Generic name (nonproprietary)
- mirtazapine
- Active ingredients
- Mirtazapine — 30 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020415
- Marketing start
- Listing expires
- Identifiers
- Product ID 78206-161_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
N478206016101followed by a unit qualifier and the quantityPackage 78206-0161-01. 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.
About NDC 78206-161
- What is NDC 78206-161?
- 78206-161 is the product NDC for Remeron (mirtazapine), Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Remeron (Mirtazapine).
- What is the active ingredient?
- Mirtazapine.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Remeron?
- 1 other product NDC are listed under this name. See all Remeron NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Remeron products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Remeronmirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-160 | 78206-0160-01 |
Other NDCs under NDA 020415
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 |
|---|---|---|---|---|
| Remeronmirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-160 |