Trazodone Hydrochloride
- Product NDC
- 60505-2654
- 11-digit product format
- 605052654
- Labeler code
- 60505
- Product ID
- 60505-2654_6761bdb4-2041-118d-35a8-4c39a8b20539
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA071196
- Marketing category
- ANDA
- Marketing start
- 2008-11-17
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trazodone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRAZODONE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6E8ZO8LRNM |
| Rxcui | 856364, 856369, 856373, 856377 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac7a3d9b-58c0-4ffc-a3eb-ed863453525e | Product name | 1 | 20250730 |
| b2f15d64-48ea-ba98-af5c-91f410667b31 | Product name | 5 | 20250314 |
| d8e7f61b-4ab5-0dbe-2706-4e11b6079b87 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-2654-0 | Trazodone Hydrochloride | 10 in 1 CARTON | TABLET | 10 | 22 | |
| 60505-2654-0 | Trazodone Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 22 | |
| 60505-2654-1 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 22 | |
| 60505-2654-5 | Trazodone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 22 | |
| 60505-2654-7 | Trazodone Hydrochloride | 9000 in 1 BOTTLE | TABLET | 9000 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-2654-0 | EA - Each | 60505-2654 | bac79318-86b4-43d5-85f6-0e35781f58cb | 1 | 2012-07-24 |
| 60505-2654-1 | EA - Each | 60505-2654 | d49a866c-6a2a-42db-b5d1-c8390f331680 | 1 | 2012-07-24 |
| 60505-2654-5 | EA - Each | 60505-2654 | 02878d29-96ab-48d4-b3d4-e3ec623a3e8a | 1 | 2012-07-24 |
| 60505-2654-7 | EA - Each | 60505-2654 | 35fc95b8-b0a9-463d-a587-9faa93aabaf6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | ACTIVE INGREDIENT | 6E8ZO8LRNM | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| TRAZODONE | ACTIVE MOIETY | YBK48BXK30 | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-2654 | TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] | 20 | Current NDC, Legacy NDC, 5 package rows | 20250322_71961ab1-951d-1493-f76c-2ff25cca2a85.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856369 | traZODone HCl 300 MG Oral Tablet | PSN | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856369 | trazodone hydrochloride 300 MG Oral Tablet | SCD | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 71961ab1-951d-1493-f76c-2ff25cca2a85 | 22 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | cbe77747-5171-447a-a0ec-26d31909642d | 9 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | cbe77747-5171-447a-a0ec-26d31909642d | 9 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | dc1f347e-1acb-4c06-b36e-f15fecb7ac93 | 8 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | dc1f347e-1acb-4c06-b36e-f15fecb7ac93 | 8 |
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 1 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60505-2654-0 | 60505265400 | 10 BLISTER PACK in 1 CARTON (60505-2654-0) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2008-11-17 | 0000-00-00 | No | No | Current |
| 60505-2654-1 | 60505265401 | 100 TABLET in 1 BOTTLE (60505-2654-1) | 100 tablet | 2008-11-17 | 0000-00-00 | No | No | Current |
| 60505-2654-5 | 60505265405 | 500 TABLET in 1 BOTTLE (60505-2654-5) | 500 tablet | 2008-11-17 | 0000-00-00 | No | No | Current |
| 60505-2654-7 | 60505265407 | 9000 TABLET in 1 BOTTLE (60505-2654-7) | 9000 tablet | 2008-11-17 | 0000-00-00 | No | No | Current |