Prescription drug · ANDA
Trazodone Hydrochloride NDC 70518-3403
Trazodone hydrochloride 100 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3403-2 | 70518340302 | 30 TABLET in 1 BLISTER PACK (70518-3403-2)Marketed from Sep 20, 2023 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071196
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3403_587640ce-b50d-2b56-e063-6294a90aa7fdSPL ID 587640ce-b50d-2b56-e063-6294a90aa7fdSPL set ID dc1f347e-1acb-4c06-b36e-f15fecb7ac93RxCUI 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
N470518340302followed by a unit qualifier and the quantityPackage 70518-3403-02. 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 071196
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 300 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0711 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Apotex Corp | 60505-2654 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Apotex Corp | 60505-2655 |
| Trazodone Hydrochloride | Trazodone hydrochloride 300 mg/1 | TabletOral | Apotex Corp | 60505-2659 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-513 |