Prescription drug · ANDA
Mirtazapine NDC 57237-013
Mirtazapine 45 mg/1 · Tablet, Orally disintegrating · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-013-06 | 57237001306 | 5 BLISTER PACK in 1 CARTON (57237-013-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 28, 2006 |
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 — 45 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 57237
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077376
- Marketing start
- Listing expires
- Identifiers
- Product ID 57237-013_ed2cd1df-697f-4e63-8097-7802be5eb6bbSPL ID ed2cd1df-697f-4e63-8097-7802be5eb6bbSPL set ID 73b7bbd9-7dba-4559-890f-3f8dd821e215RxCUI 283406, 283407, 283485UNII 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
N457237001306followed by a unit qualifier and the quantityPackage 57237-0013-06. 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 orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine orally disintegrating 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 57237-013
- What is NDC 57237-013?
- 57237-013 is the product NDC for Mirtazapine, Mirtazapine 45 mg/1 tablet, orally disintegrating, listed with the FDA by Rising Pharma Holdings, 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?
- Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 077376
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, Orally disintegratingOral | Cardinal Health 107, LLC | 55154-8335 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-011 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-012 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-021 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-022 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-023 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2978 |