Prescription drug · ANDA
Mirtazapine NDC 71610-100
Mirtazapine 30 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-100-15 | 71610010015 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-100-15)Marketed from Jul 20, 2018 | |
| 71610-100-45 | 71610010045 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-100-45)Marketed from Jul 20, 2018 | |
| 71610-100-53 | 71610010053 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-100-53)Marketed from Jul 20, 2018 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-100_b5d04e06-e889-4ccd-97eb-967ec6e00a6cSPL ID b5d04e06-e889-4ccd-97eb-967ec6e00a6cSPL set ID 6ad0e695-92ee-4900-b194-a2455473370bRxCUI 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
N471610010015followed by a unit qualifier and the quantityPackage 71610-0100-15. 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)
INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, los…
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 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 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 |
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