Trazodone Hydrochloride
- Product NDC
- 53002-2132
- 11-digit product format
- 530022132
- Labeler code
- 53002
- Product ID
- 53002-2132_e830df6f-5218-4781-87ab-6303bfa5c513
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA202180
- Marketing category
- ANDA
- Marketing start
- 2013-11-27
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-2132-0 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a274-d83d-e063-dadaa90ab31f | 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 |
| 53002-2132-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a274-d83d-e063-dadaa90ab31f | 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 |
| 53002-2132-6 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a274-d83d-e063-dadaa90ab31f | 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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2132-0 | Trazodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 53002-2132-3 | Trazodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53002-2132-6 | Trazodone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2132 | TRAZODONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 3 package rows | 20220331_5bb98507-6c62-4892-b514-782209e680d1.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 |
|---|
| 53002-2132-0 | 53002213200 | 100 TABLET in 1 BOTTLE (53002-2132-0) | 100 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-2132-3 | 53002213203 | 30 TABLET in 1 BOTTLE (53002-2132-3) | 30 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-2132-6 | 53002213206 | 60 TABLET in 1 BOTTLE (53002-2132-6) | 60 tablet | 2021-01-01 | 0000-00-00 | No | No | Current |