Prescription drug · ANDA
lurasidone hydrochloride NDC 72603-622
Lurasidone hydrochloride 40 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-622-01 | 7260306220172603062201 | 30 TABLET, FILM COATED in 1 BOTTLE (72603-622-01)Marketed from Apr 8, 2025 |
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)
- lurasidone hydrochloride
- Generic name (nonproprietary)
- lurasidone hydrochloride
- Active ingredients
- Lurasidone hydrochloride — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar RxLLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212124
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-622_10a88607-0b5e-4707-b0cb-40c58a5c6774SPL ID 10a88607-0b5e-4707-b0cb-40c58a5c6774SPL set ID 10a88607-0b5e-4707-b0cb-40c58a5c6774RxCUI 1040031, 1040041, 1235247, 1431235UNII O0P4I5851IUPC 0372603621013, 0372603622010, 0372603623017, 0372603624014
- 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
N472603062201followed by a unit qualifier and the quantityPackage 72603-0622-01. 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)
Lurasidone hydrochloride 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 (other indication) [see Clinical Studies ( 14.2 )]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (other indication) [see Clinical Studies ( 14.2 )]. Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) • Depressiv…
Excerpt only. Read the full label for complete information.
About NDC 72603-622
- What is NDC 72603-622?
- 72603-622 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 40 mg/1 tablet, film coated, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lurasidone hydrochloride.
- What is the active ingredient?
- Lurasidone hydrochloride.
- Who is the labeler?
- NorthStar RxLLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for lurasidone hydrochloride?
- 129 other product NDCs are listed under this name. See all lurasidone hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lurasidone hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lurasidone Hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-737 | 13668-0737-3013668-0737-90 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1659 | 67046-1659-03 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4563 | 70518-4563-00 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 60 mg/1 | TabletOral | Coupler LLC | 67046-1654 | 67046-1654-03 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1637 | 67046-1637-03 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4491 | 70518-4491-00 |
| lurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4427 | 70518-4427-00 |
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-621 | 72603-0621-01 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-623 | 72603-0623-01 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-624 | 72603-0624-01 |
Other NDCs under ANDA 212124
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 |
|---|---|---|---|---|
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-419 |
| lurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-420 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-421 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-422 |
| lurasidone hydrochloride | Lurasidone hydrochloride 120 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-423 |
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-621 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-623 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-624 |