Trazodone Hydrochloride
- Product NDC
- 68382-610
- 11-digit product format
- 683820610
- Labeler code
- 68382
- Product ID
- 68382-610_24cb2e4c-a9ba-4283-8396-343f6aa03121
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA205253
- Marketing category
- ANDA
- Marketing start
- 2026-01-22
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6E8ZO8LRNM | TRAZODONE HYDROCHLORIDE | 25332-39-2 | TRAZODONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-610-01 | 68382061001 | 100 TABLET in 1 BOTTLE (68382-610-01) | 100 tablet | 2026-01-22 | No | No | Historical |
| 68382-610-05 | 68382061005 | 500 TABLET in 1 BOTTLE (68382-610-05) | 500 tablet | 2026-01-22 | No | No | Historical |
| 68382-610-10 | 68382061010 | 1000 TABLET in 1 BOTTLE (68382-610-10) | 1000 tablet | 2026-01-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Trazodone Hydrochloride | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | Zydus Pharmaceuticals Limited | 2026-01-22 | HUMAN PRESCRIPTION DRUG LABEL | 9 |