Prescription drug · ANDA
Mirtazapine NDC 13107-032
Mirtazapine 45 mg/1 · Tablet, Film coated · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-032-01 | 13107003201 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-032-01)Marketed from Aug 17, 2009 | |
| 13107-032-05 | 13107003205 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-032-05)Marketed from Aug 17, 2009 | |
| 13107-032-32 | 13107003232 | 30 TABLET, FILM COATED in 1 BLISTER PACK (13107-032-32)Marketed from Aug 17, 2009 | |
| 13107-032-34 | 13107003234 | 30 TABLET, FILM COATED in 1 BOTTLE (13107-032-34)Marketed from Aug 17, 2009 | |
| 13107-032-60 | 13107003260 | 60 TABLET, FILM COATED in 1 BOTTLE (13107-032-60)Marketed from Aug 17, 2009 | |
| 13107-032-90 | 13107003290 | 90 TABLET, FILM COATED in 1 BOTTLE (13107-032-90)Marketed from Aug 17, 2009 |
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 — 45 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurolife Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
- Marketing start
- Listing expires
- Identifiers
- Product ID 13107-032_4329eeed-8071-4b6c-887d-0cd00647b84cSPL ID 4329eeed-8071-4b6c-887d-0cd00647b84cSPL set ID aa05d606-29fd-443e-802b-1d65584d6bb1RxCUI 311725, 311726, 314111, 476809UNII 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
N413107003201followed by a unit qualifier and the quantityPackage 13107-0032-01. 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)
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.
Other NDCs under ANDA 076921
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 45 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-2024 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-119 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-120 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-121 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0068 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3346 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0964 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0319 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0484 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7251 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2412 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-584 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-100 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-001 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-003 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7324 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-115 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1055 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-058 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-031 |
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