Prescription drug · ANDA
Mirtazapine NDC 51079-088
Mirtazapine 45 mg/1 · Tablet, Film coated · Oral · Mylan Institutional Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51079-088-20 | 51079008820 | 100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01)Marketed from Aug 1, 2003 |
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
- Mylan Institutional Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076122
- Marketing start
- Listing expires
- Identifiers
- Product ID 51079-088_3a87423c-fbbb-b2a4-e063-6394a90a0db3SPL ID 3a87423c-fbbb-b2a4-e063-6394a90a0db3SPL set ID 6837b69b-2f86-42cf-b48d-b4a3c7b5413fRxCUI 311725, 311726, 314111UNII 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
N451079008820followed by a unit qualifier and the quantityPackage 51079-0088-20. 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 076122
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 | 71610-523 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4322 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0280 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3515 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-351 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-350 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-352 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3530 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-3545 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-5355 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-086 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Mylan Institutional Inc. | 51079-087 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-076 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-077 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-078 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-475 |