Prescription drug · ANDA
Trazodone Hydrochloride NDC 45865-505
Trazodone hydrochloride 100 mg/1 · Tablet · Oral · Medsource Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45865-505-60 | 45865050560 | 60 TABLET in 1 BOTTLE (45865-505-60)Marketed from Nov 16, 2023 |
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)
- Trazodone Hydrochloride
- Generic name (nonproprietary)
- trazodone hydrochloride
- Active ingredients
- Trazodone hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Medsource Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202180
- Marketing start
- Listing expires
- Identifiers
- Product ID 45865-505_138fef7b-db84-88c4-e063-6394a90ab0acSPL ID 138fef7b-db84-88c4-e063-6394a90ab0acSPL set ID 138fef7b-db83-88c4-e063-6394a90ab0acRxCUI 856373UNII 6E8ZO8LRNM
- Pharmacologic class
- Serotonin Reuptake Inhibitor
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
N445865050560followed by a unit qualifier and the quantityPackage 45865-0505-60. 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)
Trazodone hydrochloride tablets, USP are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202180
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 |
|---|---|---|---|---|
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2959 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2996 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2084 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0462 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2651 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-332 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-330 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-331 |
| Trazodone Hydrochloride | Trazodone hydrochloride 300 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-333 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-588 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-591 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-7439 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3426 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0326 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3479 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 71205-505 |
| Trazodone HCL | Trazodone hydrochloride 300 mg/1 | TabletOral | Direct_Rx | 72189-569 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Proficient Rx LP | 71205-815 |