Trazodone Hydrochloride
- Product NDC
- 57664-014
- 11-digit product format
- 576640014
- Labeler code
- 57664
- Product ID
- 57664-014_323e3d63-4d8d-7088-e063-6294a90abb0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA073137
- Marketing category
- ANDA
- Marketing start
- 2022-10-03
- 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, 856373, 856377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-014-72 | Trazodone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 4 |
| 57664-014-74 | Trazodone Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 4 |
| 57664-014-75 | Trazodone Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-014 | TRAZODONE HYDROCHLORIDE TABLET, FILM COATED TRAZODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 4 | Current NDC, 3 package rows | 20250412_f291b905-a739-5e43-e053-2995a90ac40c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-014-72 | 57664001472 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72) | 2022-10-03 | No | No | Current |
| 57664-014-74 | 57664001474 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74) | 2022-10-03 | No | No | Current |
| 57664-014-75 | 57664001475 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75) | 2022-10-03 | No | No | Current |