Prescription drug · ANDA
Trazodone Hydrochloride NDC 70518-4363
Trazodone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4363-0 | 70518436300 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4363-0)Marketed from Jun 18, 2025 | |
| 70518-4363-1 | 70518436301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4363-1)Marketed from Jul 11, 2025 |
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)
- Trazodone Hydrochloride
- Generic name (nonproprietary)
- trazodone hydrochloride
- Active ingredients
- Trazodone hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073137
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4363_5afe0778-c45c-6b25-e063-6394a90a7aa3SPL ID 5afe0778-c45c-6b25-e063-6394a90a7aa3SPL set ID fa7afa93-b98c-4dc7-bbb8-ab6a058427b9RxCUI 856377UNII 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
N470518436300followed by a unit qualifier and the quantityPackage 70518-4363-00. 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 073137
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 | Coupler LLC | 67046-1662 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1684 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-014 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-026 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-053 |