Prescription drug · ANDA
Mirtazapine NDC 63629-2367
Mirtazapine 15 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2367-1 | 6362923670163629236701 | 30 TABLET in 1 BOTTLE (63629-2367-1)Marketed from Apr 22, 2004 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076541
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2367_15c0f230-313e-4102-bef5-e504778e1fb2SPL ID 15c0f230-313e-4102-bef5-e504778e1fb2SPL set ID ecf7826c-c583-4836-9b00-bf9e4b51a144RxCUI 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
N463629236701followed by a unit qualifier and the quantityPackage 63629-2367-01. 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 63629-2367
- What is NDC 63629-2367?
- 63629-2367 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 076541
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 | TabletOral | AvKARE | 42291-494 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-499 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-500 |
| Mirtazapine | Mirtazapine 45 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-501 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-510 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2366 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2368 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4548 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0286 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0441 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2963 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-713 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1639 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1640 |