Prescription drug · ANDA
Mirtazapine NDC 61919-153
Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-153-60 | 61919015360 | 60 TABLET, FILM COATED in 1 BOTTLE (61919-153-60)Marketed from May 10, 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 — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 61919
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
- Marketing start
- Listing expires
- Identifiers
- Product ID 61919-153_47e14699-4104-6433-e063-6394a90acbccSPL ID 47e14699-4104-6433-e063-6394a90acbccSPL set ID dea8c09a-b759-1da7-e053-2a95a90a3346RxCUI 311725UNII 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
N461919015360followed by a unit qualifier and the quantityPackage 61919-0153-60. 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 .
Indications (excerpt from the label)
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].
Excerpt only. Read the full label for complete information.
About NDC 61919-153
- What is NDC 61919-153?
- 61919-153 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. 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?
- Direct_Rx, NDC labeler code 61919. 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 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 30 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-952 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6519 |