Prescription drug · ANDA
Mirtazapine NDC 66993-606
Mirtazapine 7.5 mg/1 · Tablet, Film coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-606-04 | 66993060604 | 500 TABLET, FILM COATED in 1 BOTTLE (66993-606-04)Marketed from Jun 1, 2023 | |
| 66993-606-30 | 66993060630 | 30 TABLET, FILM COATED in 1 BOTTLE (66993-606-30)Marketed from Jun 1, 2023 |
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 — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216751
- Marketing start
- Listing expires
- Identifiers
- Product ID 66993-606_e1a19354-1c97-49ed-8ec9-bb895dbe69f3SPL ID e1a19354-1c97-49ed-8ec9-bb895dbe69f3SPL set ID 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4RxCUI 311725, 311726, 314111, 476809UNII A051Q2099QUPC 0366993607306, 0366993607047, 0366993608044
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
N466993060604followed by a unit qualifier and the quantityPackage 66993-0606-04. 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 216751
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 | Prasco Laboratories | 66993-608 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-607 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-609 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-846 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-853 |