Prescription drug · ANDA
Mirtazapine NDC 0615-8663
Mirtazapine 7.5 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8663-05 | 00615866305 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8663-05)Marketed from Sep 16, 2026 | |
| 0615-8663-39 | 00615866339 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8663-39)Marketed from Sep 16, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219919
- Marketing start
- Listing expires
- Identifiers
- Product ID 0615-8663_65d56a7a-38e7-4132-96d0-d568757472e4SPL ID 65d56a7a-38e7-4132-96d0-d568757472e4
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
N400615866305followed by a unit qualifier and the quantityPackage 00615-8663-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0615-8663
- What is NDC 0615-8663?
- 0615-8663 is the product NDC for Mirtazapine, Mirtazapine 7.5 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mirtazapine.
- What is the active ingredient?
- Mirtazapine.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mirtazapine?
- 138 other product NDCs are listed under this name. See all Mirtazapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mirtazapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0319 | 67046-0319-03 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0280 | 55154-0280-00 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0625 | 67046-0625-03 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-2024 | 67046-2024-03 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-830 | 70954-0830-10 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0484 | 67046-0484-03 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0068 | 67046-0068-03 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-077 | 48433-0077-20 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-078 | 48433-0078-20 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-076 | 48433-0076-20 |
Other NDCs under ANDA 219919
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 7.5 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-830 |