Prescription drug · ANDA
Trazodone Hydrochloride NDC 52817-396
Trazodone hydrochloride 75 mg/1 · Tablet, Film coated · Oral · TRUPHARMA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-396-10 | 52817039610 | 100 TABLET, FILM COATED in 1 BOTTLE (52817-396-10)Marketed from Sep 3, 2026 |
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 — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TRUPHARMA LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072193
- Marketing start
- Listing expires
- Identifiers
- Product ID 52817-396_203c92fc-3666-44b8-b89c-0b1acf94f137SPL ID 203c92fc-3666-44b8-b89c-0b1acf94f137SPL set ID a57da4f8-151d-4a74-8710-6158d1da3852RxCUI 2751852, 2751854UNII 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
N452817039610followed by a unit qualifier and the quantityPackage 52817-0396-10. 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 are indicated for the treatment of major depressive disorder (MDD) in adults . Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072193
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 | Tablet, Film coatedOral | Oxford Pharmaceuticals, LLC | 69584-885 |
| Trazodone Hydrochloride | Trazodone hydrochloride 25 mg/1 | Tablet, Film coatedOral | TRUPHARMA LLC | 52817-395 |