Prescription drug · ANDA
Mirtazapine NDC 65862-021
Mirtazapine 15 mg/1 · Tablet, Orally disintegrating · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-021-01 | 65862002101 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01)Marketed from Dec 8, 2005 | |
| 65862-021-06 | 65862002106 | 5 BLISTER PACK in 1 CARTON (65862-021-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 8, 2005 | |
| 65862-021-30 | 65862002130 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30)Marketed from Dec 8, 2005 | |
| 65862-021-60 | 65862002160 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60)Marketed from Dec 8, 2005 | |
| 65862-021-90 | 65862002190 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90)Marketed from Dec 8, 2005 |
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, Orally disintegrating
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077376
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-021_04494335-fcd8-47b2-a573-98a214f07ff6SPL ID 04494335-fcd8-47b2-a573-98a214f07ff6SPL set ID 3a8a4490-9243-4201-944d-cea27d3d69f5RxCUI 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
N465862002101followed by a unit qualifier and the quantityPackage 65862-0021-01. 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 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 65862-021
- What is NDC 65862-021?
- 65862-021 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, orally disintegrating, listed with the FDA by Aurobindo Pharma Limited. It has 5 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 45 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-078 | 48433-0078-20 |
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 | Rising Pharma Holdings, Inc. | 57237-011 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-012 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-013 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2978 |
| 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 15 mg/1 | Tablet, Orally disintegratingOral | Cardinal Health 107, LLC | 55154-8335 |