Prescription drug · ANDA
Trazodone Hydrochloride NDC 67046-1506
Trazodone hydrochloride 50 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1506-3 | 67046150603 | 30 TABLET in 1 BLISTER PACK (67046-1506-3)Marketed from Jan 24, 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
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218988
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1506_2cb18efa-16e1-b2f6-e063-6394a90a0d68SPL ID 2cb18efa-16e1-b2f6-e063-6394a90a0d68SPL set ID 2c7dca0c-8313-7d85-e063-6294a90aca61RxCUI 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
N467046150603followed by a unit qualifier and the quantityPackage 67046-1506-03. 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 218988
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 | REMEDYREPACK INC. | 70518-4737 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4760 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1540 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-233 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-080 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-231 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-232 |
| Trazodone Hydrochloride | Trazodone hydrochloride 300 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-234 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-946 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-947 |