RALDESY
- Product NDC
- 30698-455
- 11-digit product format
- 306980455
- Labeler code
- 30698
- Product ID
- 30698-455_490e0fcd-3542-c976-e063-6294a90ac2ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAZODONE HYDROCHLORIDE ORAL
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Validus Pharmaceuticals LLC
- Application
- NDA218637
- Marketing category
- NDA
- Marketing start
- 2024-11-26
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- 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
- RALDESY
- Brand name suffix
- TM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAZODONE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6E8ZO8LRNM |
| Rxcui | 856381, 2699618 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 30698-455-01 | RALDESYTM | 300 mL in 1 BOTTLE | SOLUTION | 300 | | 4 |
| 30698-455-02 | RALDESYTM | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 4 |
| 30698-455-03 | RALDESYTM | 150 mL in 1 BOTTLE, GLASS | SOLUTION | 150 | | 4 |
| 30698-455-04 | RALDESYTM | 300 mL in 1 BOTTLE, GLASS | SOLUTION | 300 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 30698-455 | RALDESY TM (TRAZODONE HYDROCHLORIDE ORAL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] | 3 | Current NDC, 4 package rows | 20250406_34708cc1-b0b2-4fd0-b9f3-7f008b457fc9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 30698-455-01 | 30698045501 | 300 mL in 1 BOTTLE (30698-455-01) | 300 ml | 2024-11-26 | No | No | Current |
| 30698-455-02 | 30698045502 | 150 mL in 1 BOTTLE (30698-455-02) | 150 ml | 2024-11-26 | No | No | Current |
| 30698-455-03 | 30698045503 | 150 mL in 1 BOTTLE, GLASS (30698-455-03) | 150 ml | 2024-11-26 | No | No | Current |
| 30698-455-04 | 30698045504 | 300 mL in 1 BOTTLE, GLASS (30698-455-04) | 300 ml | 2024-11-26 | No | No | Current |