Prescription drug · ANDA
mirtazapine NDC 50090-8019
Mirtazapine 7.5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-8019-0 | 50090801900 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-8019-0)Marketed from Jul 20, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219721
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-8019_b5e85384-c00b-4e41-b95f-e3046c6b036dSPL ID b5e85384-c00b-4e41-b95f-e3046c6b036dSPL set ID 222dfdde-6979-4b18-a7eb-ff1ad0a437c1RxCUI 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
N450090801900followed by a unit qualifier and the quantityPackage 50090-8019-00. 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.
About NDC 50090-8019
- What is NDC 50090-8019?
- 50090-8019 is the product NDC for mirtazapine, Mirtazapine 7.5 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 15 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-076 | 48433-0076-20 |
Other NDCs under ANDA 219721
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 7.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-407 |
| mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-408 |
| mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-409 |
| mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-410 |
| mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-368 |
| mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-369 |
| mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-370 |
| mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-371 |