CAPLYTA
- Product NDC
- 70518-3497
- 11-digit product format
- 705183497
- Labeler code
- 70518
- Product ID
- 70518-3497_e7101e78-2736-432f-e053-2995a90addec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lumateperone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA209500
- Marketing category
- NDA
- Marketing start
- 2022-08-24
- Marketing end
- 0000-00-00
- Substance
- LUMATEPERONE
- Active strength
- 42 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3497-0 | 70518349700 | 30 POUCH in 1 BOX (70518-3497-0) > 1 CAPSULE in 1 POUCH (70518-3497-1) | 30 pouch | 2022-08-24 | 0000-00-00 | No | No | Current |