Trazodone Hydrochloride
- Product NDC
- 68382-609
- 11-digit product format
- 683820609
- Labeler code
- 68382
- Product ID
- 68382-609_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
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trazodone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAZODONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6E8ZO8LRNM |
| Rxcui | 856364, 856369, 856373, 856377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-609-01 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 68382-609-05 | Trazodone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 68382-609-10 | Trazodone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-609-01 | 68382060901 | 100 TABLET in 1 BOTTLE (68382-609-01) | 100 tablet | 2026-01-22 | No | No | Current |
| 68382-609-05 | 68382060905 | 500 TABLET in 1 BOTTLE (68382-609-05) | 500 tablet | 2026-01-22 | No | No | Current |
| 68382-609-10 | 68382060910 | 1000 TABLET in 1 BOTTLE (68382-609-10) | 1000 tablet | 2026-01-22 | No | No | Current |