TRAZODONE HYDROCHLORIDE
- Product NDC
- 13107-079
- 11-digit product format
- 131070079
- Labeler code
- 13107
- Product ID
- 13107-079_db4e6aff-149f-4f16-9512-e81e0c3e6900
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAZODONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA204852
- Marketing category
- ANDA
- Marketing start
- 2015-09-15
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRAZODONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
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 |
|---|
| 13107-079-01 | TRAZODONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 13107-079-05 | TRAZODONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 13107-079-30 | TRAZODONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 13107-079-99 | TRAZODONE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-079 | TRAZODONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250412_295e92a9-bcb0-4d53-ba62-e30020e9834b.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 |
|---|
| 13107-079-01 | 13107007901 | 100 TABLET in 1 BOTTLE (13107-079-01) | 100 tablet | 2015-09-15 | 0000-00-00 | No | No | Current |
| 13107-079-05 | 13107007905 | 500 TABLET in 1 BOTTLE (13107-079-05) | 500 tablet | 2015-09-15 | 0000-00-00 | No | No | Current |
| 13107-079-30 | 13107007930 | 30 TABLET in 1 BOTTLE (13107-079-30) | 30 tablet | 2015-09-15 | 0000-00-00 | No | No | Current |
| 13107-079-99 | 13107007999 | 1000 TABLET in 1 BOTTLE (13107-079-99) | 1000 tablet | 2015-09-15 | 0000-00-00 | No | No | Current |