Prescription drug · ANDA
Mirtazapine NDC 71205-481
Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-481-30 | 71205048130 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-481-30)Marketed from Oct 1, 2020 | |
| 71205-481-60 | 71205048160 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-481-60)Marketed from Oct 1, 2020 | |
| 71205-481-90 | 71205048190 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-481-90)Marketed from Oct 1, 2020 |
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
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-481_cc15149e-2921-468f-a145-513b01885a81SPL ID cc15149e-2921-468f-a145-513b01885a81SPL set ID 0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1RxCUI 311725UNII A051Q2099QUPC 0371205481308
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
N471205048130followed by a unit qualifier and the quantityPackage 71205-0481-30. 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 71205-481
- What is NDC 71205-481?
- 71205-481 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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 30 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-003 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1309 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-001 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2453 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0625 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2140 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-008 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-007 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-010 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-403 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-009 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2562 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1397 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9255 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-031 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0664 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-032 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2581 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-558 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 |
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