Prescription drug · ANDA
Trazodone Hydrochloride NDC 70518-2973
Trazodone hydrochloride 100 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2973-0 | 70518297300 | 30 TABLET in 1 BLISTER PACK (70518-2973-0)Marketed from Jan 12, 2021 | |
| 70518-2973-2 | 70518297302 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2973-2)Marketed from Jun 9, 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)
- 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 071524
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-2973_57e9b9cb-9978-b908-e063-6394a90ad848SPL ID 57e9b9cb-9978-b908-e063-6394a90ad848SPL set ID 7bba99e5-4096-4fcb-8591-dc4a9bfe975eRxCUI 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
N470518297300followed by a unit qualifier and the quantityPackage 70518-2973-00. 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 071524
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 | Northwind Health Company, LLC | 51655-986 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-530 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-537 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-424 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 50111-561 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | AvKARE | 42291-869 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 71205-574 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8386 |