Trazodone Hydrochloride
- Product NDC
- 64725-0434
- 11-digit product format
- 647250434
- Labeler code
- 64725
- Product ID
- 64725-0434_476c6f63-97d9-4142-b778-58d72af4ab38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA071524
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0434-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3738-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use TRAZODONE hydrochloride tablets USP safely and effectively. See full prescribing information for TRAZODONE hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral use Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0434-1 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | ACTIVE INGREDIENT | 6E8ZO8LRNM | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| TRAZODONE | ACTIVE MOIETY | YBK48BXK30 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0434 | TRAZODONE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140828_2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 2c4d7005-a0d0-4e9b-a36f-b7dc1f2bf7ec | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0434-1 | 64725043401 | 100 in 1 BOTTLE | Historical |