Trazodone Hydrochloride
- Product NDC
- 68382-808
- 11-digit product format
- 683820808
- Labeler code
- 68382
- Product ID
- 68382-808_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
- 2017-12-11
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 300 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 | 300 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 |
|---|
| 68382-808-01 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 68382-808-05 | Trazodone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 68382-808-06 | Trazodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 68382-808-10 | Trazodone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
| 68382-808-16 | Trazodone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
| 68382-808-30 | Trazodone Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 9 |
| 68382-808-77 | Trazodone Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-808 | TRAZODONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 7 package rows | 20250503_704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-808-01 | 68382080801 | 100 TABLET in 1 BOTTLE (68382-808-01) | 100 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |
| 68382-808-05 | 68382080805 | 500 TABLET in 1 BOTTLE (68382-808-05) | 500 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |
| 68382-808-06 | 68382080806 | 30 TABLET in 1 BOTTLE (68382-808-06) | 30 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |
| 68382-808-10 | 68382080810 | 1000 TABLET in 1 BOTTLE (68382-808-10) | 1000 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |
| 68382-808-16 | 68382080816 | 90 TABLET in 1 BOTTLE (68382-808-16) | 90 tablet | 2017-12-11 | 0000-00-00 | No | No | Current |
| 68382-808-30 | 68382080830 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-808-77 | 68382080877 | 10 BLISTER PACK in 1 CARTON (68382-808-77) / 10 TABLET in 1 BLISTER PACK (68382-808-30) | 10 blister pack | 2017-12-11 | 0000-00-00 | No | No | Current |