Prescription drug · ANDA
Mirtazapine NDC 87441-058
Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Unit Dose Solutions, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87441-058-01 | 8744100580187441005801 | 30 TABLET, FILM COATED in 1 BLISTER PACK (87441-058-01)Marketed from Jun 27, 2026 |
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 — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Unit Dose Solutions, Inc.NDC labeler code 87441
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
- Marketing start
- Listing expires
- Identifiers
- Product ID 87441-058_553a1bdd-a992-688f-e063-6394a90a7ccfSPL ID 553a1bdd-a992-688f-e063-6394a90a7ccfSPL set ID 5539fe37-546b-40a8-e063-6394a90ace1bRxCUI 311725UNII 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
N487441005801followed by a unit qualifier and the quantityPackage 87441-0058-01. 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.
About NDC 87441-058
- What is NDC 87441-058?
- 87441-058 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by Unit Dose Solutions, Inc.. 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?
- Unit Dose Solutions, Inc., NDC labeler code 87441. 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 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 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8269 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8489 |
| 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 15 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-031 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-032 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | ATLANTIC BIOLOGICALS CORP. | 17856-0101 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2140 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2558 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2800 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-007 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-008 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-009 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-010 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-584 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-403 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3346 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9255 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-003 |
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