Prescription drug · ANDA
lurasidone hydrochloride NDC 70518-4427
Lurasidone hydrochloride 40 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4427-0 | 7051844270070518442700 | 30 TABLET in 1 BLISTER PACK (70518-4427-0)Marketed from Aug 6, 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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208031
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4427_5b265037-bc4d-467d-e063-6394a90a32f9SPL ID 5b265037-bc4d-467d-e063-6394a90a32f9
- 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
N470518442700followed by a unit qualifier and the quantityPackage 70518-4427-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4427
- What is NDC 70518-4427?
- 70518-4427 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 40 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-622 | 72603-0622-01 |
| 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 208031
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 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-670 |
| lurasidone hydrochloride | Lurasidone hydrochloride 40 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-671 |
| lurasidone hydrochloride | Lurasidone hydrochloride 60 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-672 |
| lurasidone hydrochloride | Lurasidone hydrochloride 80 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-673 |
| lurasidone hydrochloride | Lurasidone hydrochloride 120 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-674 |