Prescription drug · ANDA
Mirtazapine NDC 42291-952
Mirtazapine 30 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-952-50 | 42291095250 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-952-50)Marketed from May 20, 2025 |
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, Film coated
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
- Marketing start
- Listing expires
- Identifiers
- Product ID 42291-952_35923954-c6ec-3d84-e063-6394a90aecf4SPL ID 35923954-c6ec-3d84-e063-6394a90aecf4SPL set ID 35922615-7619-3852-e063-6394a90a2e55RxCUI 314111UNII A051Q2099QUPC 0342291952508
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
N442291095250followed by a unit qualifier and the quantityPackage 42291-0952-50. 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 tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42291-952
- What is NDC 42291-952?
- 42291-952 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, 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?
- AvKARE, NDC labeler code 42291. 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8663 | 00615-8663-0500615-8663-39 |
| 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 |
Other NDCs under ANDA 077666
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, Film coatedOral | Direct_Rx | 61919-153 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-378 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | McKesson Corporation dba SKY Packaging | 63739-098 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | McKesson Corporation dba SKY Packaging | 63739-099 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1058 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1590 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-471 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0247 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0248 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-0249 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-554 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-717 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7297 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-206 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6519 |