Prescription drug · ANDA
Mirtazapine NDC 71335-0286
Mirtazapine 15 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0286-1 | 71335028601 | 30 TABLET in 1 BOTTLE (71335-0286-1)Marketed from Sep 9, 2021 | |
| 71335-0286-2 | 71335028602 | 60 TABLET in 1 BOTTLE (71335-0286-2)Marketed from Nov 8, 2021 | |
| 71335-0286-3 | 71335028603 | 90 TABLET in 1 BOTTLE (71335-0286-3)Marketed from Dec 27, 2021 | |
| 71335-0286-4 | 71335028604 | 120 TABLET in 1 BOTTLE (71335-0286-4)Marketed from Dec 27, 2021 | |
| 71335-0286-5 | 71335028605 | 15 TABLET in 1 BOTTLE (71335-0286-5)Marketed from Dec 27, 2021 | |
| 71335-0286-6 | 71335028606 | 180 TABLET in 1 BOTTLE (71335-0286-6)Marketed from Dec 27, 2021 | |
| 71335-0286-7 | 71335028607 | 45 TABLET in 1 BOTTLE (71335-0286-7)Marketed from Dec 27, 2021 | |
| 71335-0286-8 | 71335028608 | 21 TABLET in 1 BOTTLE (71335-0286-8)Marketed from Dec 27, 2021 |
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 Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076541
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-0286_7bcab2eb-126f-4e34-949a-a7002e06ed12SPL ID 7bcab2eb-126f-4e34-949a-a7002e06ed12SPL set ID 9f0f52e8-3318-4da2-b0d9-ea3d33bfe41eRxCUI 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
N471335028601followed by a unit qualifier and the quantityPackage 71335-0286-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 15 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-499 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-713 |
| 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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0441 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4548 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2963 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2366 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | TabletOral | AvKARE | 42291-494 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2367 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2368 |
| Mirtazapine | Mirtazapine 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1639 |
| Mirtazapine | Mirtazapine 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1640 |