NDC 72060-142
CAPLYTA
Lumateperone
CAPLYTA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Intra-cellular Therapies, Inc. The primary component is Lumateperone.
| Product ID | 72060-142_3916c6bb-0b58-4366-a339-d9610300304c |
| NDC | 72060-142 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CAPLYTA |
| Generic Name | Lumateperone |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-02-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA209500 |
| Labeler Name | Intra-Cellular Therapies, Inc |
| Substance Name | LUMATEPERONE |
| Active Ingredient Strength | 42 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 72060-142-30
3 BLISTER PACK in 1 CARTON (72060-142-30) > 10 CAPSULE in 1 BLISTER PACK (72060-142-01)
| Marketing Start Date | 2020-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 72060-142-01 [72060014201]
CAPLYTA CAPSULE
| Marketing Category | NDA |
| Application Number | NDA209500 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-01 |
NDC 72060-142-05 [72060014205]
CAPLYTA CAPSULE
| Marketing Category | NDA |
| Application Number | NDA209500 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-01 |
NDC 72060-142-30 [72060014230]
CAPLYTA CAPSULE
| Marketing Category | NDA |
| Application Number | NDA209500 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-02-01 |
NDC 72060-142-10 [72060014210]
CAPLYTA CAPSULE
| Marketing Category | NDA |
| Application Number | NDA209500 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-02-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LUMATEPERONE | 42 mg/1 |
OpenFDA Data
| SPL SET ID: | db730b06-6351-47fd-8183-e61e61bbead5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "CAPLYTA" or generic name "Lumateperone"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70518-3497 | CAPLYTA | lumateperone |
| 72060-110 | CAPLYTA | lumateperone |
| 72060-121 | CAPLYTA | lumateperone |
| 72060-142 | CAPLYTA | lumateperone |
Trademark Results [CAPLYTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPLYTA 88742518 not registered Live/Pending |
INTRA-CELLULAR THERAPIES, INC. 2019-12-30 |
 CAPLYTA 88742498 not registered Live/Pending |
INTRA-CELLULAR THERAPIES, INC. 2019-12-30 |
 CAPLYTA 88340176 not registered Live/Pending |
INTRA-CELLULAR THERAPIES, INC. 2019-03-14 |
 CAPLYTA 87334055 not registered Live/Pending |
INTRA-CELLULAR THERAPIES, INC. 2017-02-13 |
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