Prescription drug · ANDA
lurasidone hydrochloride NDC 70518-4260
Lurasidone hydrochloride 20 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4260-0 | 70518426000 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4260-0)Marketed from Jan 22, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212244
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4260_5a71017a-dd08-b810-e063-6294a90a3f14SPL ID 5a71017a-dd08-b810-e063-6294a90a3f14SPL set ID 6008ccac-948e-4b6a-a288-7dd245c2bac4RxCUI 1235247UNII O0P4I5851I
- 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
N470518426000followed by a unit qualifier and the quantityPackage 70518-4260-00. 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 tablets are indicated for: • 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 )]. Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: • Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) • Depressive episode…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212244
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 60 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-769 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-780 |
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7355 |
| lurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7356 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7357 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7358 |
| lurasidone hydrochloride | Lurasidone hydrochloride 120 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7359 |
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7170 |
| lurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-639 |
| lurasidone hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-638 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-747 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-640 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-641 |
| lurasidone hydrochloride | Lurasidone hydrochloride 120 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-642 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-758 |