VERSACLOZ
- Product NDC
- 52817-601
- 11-digit product format
- 528170601
- Labeler code
- 52817
- Product ID
- 52817-601_38837e2a-084f-4179-e063-6394a90afd45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clozapine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- TruPharma LLC
- Application
- NDA203479
- Marketing category
- NDA
- Marketing start
- 2018-06-15
- Substance
- CLOZAPINE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VERSACLOZ
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOZAPINE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J60AR2IKIC |
| Rxcui | 1369825, 1369831 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-601-38 | VERSACLOZ | 100 mL in 1 BOTTLE | SUSPENSION | 100 | | 6 |
| 52817-601-38 | VERSACLOZ | 1 in 1 BOX | SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-601 | VERSACLOZ (CLOZAPINE) SUSPENSION [TRUPHARMA LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250207_2592c9a8-fd74-4e0d-a895-b07b014cf355.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 |
|---|
| 52817-601-38 | 52817060138 | 1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE | 1 bottle | 2018-06-15 | 0000-00-00 | No | No | Current |