Trazodone Hydrochloride
- Product NDC
- 0615-8386
- 11-digit product format
- 006158386
- Labeler code
- 0615
- Product ID
- 0615-8386_caf3ae1d-6e29-4386-96bb-0d0acb99e376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA071524
- Marketing category
- ANDA
- Marketing start
- 2020-10-08
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAZODONE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6E8ZO8LRNM |
| Rxcui | 856373 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8386-05 | Trazodone Hydrochloride | 15 in 1 BLISTER PACK | TABLET | 15 | | 30 |
| 0615-8386-28 | Trazodone Hydrochloride | 28 in 1 BLISTER PACK | TABLET | 28 | | 30 |
| 0615-8386-39 | Trazodone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8386 | TRAZODONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250129_df17cec9-ad5e-4e57-8572-c927c9b955e2.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 |
|---|
| 0615-8386-05 | 00615838605 | 15 TABLET in 1 BLISTER PACK (0615-8386-05) | 15 tablet | 2021-02-10 | 0000-00-00 | No | No | Current |
| 0615-8386-28 | 00615838628 | 28 TABLET in 1 BLISTER PACK (0615-8386-28) | 28 tablet | 2025-01-22 | | No | No | Historical |
| 0615-8386-39 | 00615838639 | 30 TABLET in 1 BLISTER PACK (0615-8386-39) | 30 tablet | 2021-02-10 | 0000-00-00 | No | No | Current |