Prescription drug · NDA
Latuda (Lurasidone hydrochloride) NDC 63402-312
Lurasidone hydrochloride 120 mg/1 · Tablet, Film coated · Oral · Sumitomo Pharma America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63402-312-04 | 6340203120463402031204 | 4 BLISTER PACK in 1 CARTON (63402-312-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-07)Marketed from Apr 26, 2012 | |
| 63402-312-10 | 6340203121063402031210 | 10 BLISTER PACK in 1 CARTON (63402-312-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-312-01)Marketed from Apr 26, 2012 | |
| 63402-312-30 | 6340203123063402031230 | 30 TABLET, FILM COATED in 1 BOTTLE (63402-312-30)Marketed from Apr 26, 2012 | |
| 63402-312-50 | 6340203125063402031250 | 500 TABLET, FILM COATED in 1 BOTTLE (63402-312-50)Marketed from Apr 26, 2012 | |
| 63402-312-90 | 6340203129063402031290 | 90 TABLET, FILM COATED in 1 BOTTLE (63402-312-90)Marketed from Apr 26, 2012 |
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)
- Latuda
- Generic name (nonproprietary)
- lurasidone hydrochloride
- Active ingredients
- Lurasidone hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sumitomo Pharma America, Inc.NDC labeler code 63402
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200603
- Marketing start
- Listing expires
- Identifiers
- Product ID 63402-312_7383b0e0-01e8-4778-96f0-6f2e0c9586aeSPL ID 7383b0e0-01e8-4778-96f0-6f2e0c9586aeSPL set ID afad3051-9df2-4c54-9684-e8262a133af8RxCUI 1040031, 1040036, 1040041, 1040043, 1235247, 1235249, 1297278, 1297357, 1431235, 1431237UNII O0P4I5851IUPC 0363402306300, 0363402302302, 0363402304306, 0363402312301, 0363402306102, 0363402306508, 0363402308304, 0363402306904
- 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
N463402031204followed by a unit qualifier and the quantityPackage 63402-0312-04. 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)
LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) Depressive episode associated with Bipolar I Dis…
Excerpt only. Read the full label for complete information.
About NDC 63402-312
- What is NDC 63402-312?
- 63402-312 is the product NDC for Latuda (lurasidone hydrochloride), Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Sumitomo Pharma America, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Latuda (Lurasidone hydrochloride).
- What is the active ingredient?
- Lurasidone hydrochloride.
- Who is the labeler?
- Sumitomo Pharma America, Inc., NDC labeler code 63402. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Latuda?
- 4 other product NDCs are listed under this name. See all Latuda NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Latuda products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-306 | 63402-0306-0463402-0306-1063402-0306-30+2 more |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-302 | 63402-0302-0463402-0302-1063402-0302-30+2 more |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-304 | 63402-0304-0463402-0304-1063402-0304-30+2 more |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-308 | 63402-0308-0463402-0308-1063402-0308-30+2 more |
Other NDCs under NDA 200603
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 |
|---|---|---|---|---|
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-302 |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-304 |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-306 |
| Latudalurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Sumitomo Pharma America, Inc. | 63402-308 |