CAPLYTA
- Product NDC
- 72060-142
- 11-digit product format
- 720600142
- Labeler code
- 72060
- Product ID
- 72060-142_160162e3-e8aa-4783-bd98-adf4c96ad2c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lumateperone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Intra-Cellular Therapies, Inc
- Application
- NDA209500
- Marketing category
- NDA
- Marketing start
- 2020-02-01
- Substance
- LUMATEPERONE
- Active strength
- 42 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CAPLYTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUMATEPERONE | 42 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 70BSQ12069 |
| Rxcui | 2275607, 2275613, 2607529, 2607531, 2607533, 2607535 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72060-142-07 | CAPLYTA | 7 in 1 BOTTLE | CAPSULE | 7 | | 26 |
| 72060-142-40 | CAPLYTA | 30 in 1 BOTTLE | CAPSULE | 30 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72060-142 | CAPLYTA (LUMATEPERONE) CAPSULE [INTRA-CELLULAR THERAPIES, INC] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240927_db730b06-6351-47fd-8183-e61e61bbead5.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 |
|---|
| 72060-142-05 | 72060014205 | 3 BLISTER PACK in 1 CARTON (72060-142-05) > 10 CAPSULE in 1 BLISTER PACK (72060-142-01) | 3 blister pack | 2020-02-01 | 0000-00-00 | Yes | No | Current |
| 72060-142-07 | 72060014207 | 7 CAPSULE in 1 BOTTLE (72060-142-07) | 7 capsule | 2021-11-01 | | Yes | No | Current |
| 72060-142-10 | 72060014210 | 1 BLISTER PACK in 1 CARTON (72060-142-10) > 10 CAPSULE in 1 BLISTER PACK (72060-142-01) | 1 blister pack | 2020-02-01 | 0000-00-00 | Yes | No | Current |
| 72060-142-30 | 72060014230 | 3 BLISTER PACK in 1 CARTON (72060-142-30) > 10 CAPSULE in 1 BLISTER PACK (72060-142-01) | 3 blister pack | 2020-02-01 | 0000-00-00 | No | No | Current |
| 72060-142-40 | 72060014240 | 30 CAPSULE in 1 BOTTLE (72060-142-40) | 30 capsule | 2022-04-01 | 0000-00-00 | No | No | Current |