Prescription drug · NDA
Caplyta (Lumateperone) NDC 72060-110
Lumateperone 10.5 mg/1 · Capsule · Oral · Intra-Cellular Therapies, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72060-110-07 | 72060011007 | 7 CAPSULE in 1 BOTTLE (72060-110-07)Marketed from Jun 1, 2023 | |
| 72060-110-40 | 72060011040 | 30 CAPSULE in 1 BOTTLE (72060-110-40)Marketed from Aug 9, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Caplyta
- Generic name (nonproprietary)
- lumateperone
- Active ingredients
- Lumateperone — 10.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Intra-Cellular Therapies, IncNDC labeler code 72060
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209500
- Marketing start
- Listing expires
- Identifiers
- Product ID 72060-110_fa0963da-0db0-41f8-bb1a-153908a8bd77SPL ID fa0963da-0db0-41f8-bb1a-153908a8bd77SPL set ID db730b06-6351-47fd-8183-e61e61bbead5RxCUI 2275607, 2275613, 2607529, 2607531, 2607533, 2607535UNII 70BSQ12069UPC 0372060110402, 0372060121408
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472060011007followed by a unit qualifier and the quantityPackage 72060-0110-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or va…
Excerpt only. Read the full label for complete information.
About NDC 72060-110
- What is NDC 72060-110?
- 72060-110 is the product NDC for Caplyta (lumateperone), Lumateperone 10.5 mg/1 capsule, listed with the FDA by Intra-Cellular Therapies, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caplyta (Lumateperone).
- What is the active ingredient?
- Lumateperone.
- Who is the labeler?
- Intra-Cellular Therapies, Inc, NDC labeler code 72060. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caplyta?
- 2 other product NDCs are listed under this name. See all Caplyta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Caplyta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Caplytalumateperone | Lumateperone 21 mg/1 | CapsuleOral | Intra-Cellular Therapies, Inc | 72060-121 | 72060-0121-0772060-0121-40 |
| Caplytalumateperone | Lumateperone 42 mg/1 | CapsuleOral | Intra-Cellular Therapies, Inc | 72060-142 | 72060-0142-0772060-0142-40 |
Other NDCs under NDA 209500
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Caplytalumateperone | Lumateperone 21 mg/1 | CapsuleOral | Intra-Cellular Therapies, Inc | 72060-121 |
| Caplytalumateperone | Lumateperone 42 mg/1 | CapsuleOral | Intra-Cellular Therapies, Inc | 72060-142 |