Prescription drug · ANDA
Lurasidone Hydrochloride NDC 13668-467
Lurasidone hydrochloride 120 mg/1 · Tablet, Film coated · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-467-30 | 13668046730 | 30 TABLET, FILM COATED in 1 BOTTLE (13668-467-30)Marketed from Jan 3, 2019 | |
| 13668-467-90 | 13668046790 | 90 TABLET, FILM COATED in 1 BOTTLE (13668-467-90)Marketed from Jan 3, 2019 |
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 — 120 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208055
- Marketing start
- Listing expires
- Identifiers
- Product ID 13668-467_e535c6d5-718e-489b-ad51-7d34dfabcec5SPL ID e535c6d5-718e-489b-ad51-7d34dfabcec5SPL set ID 9cb5e275-1029-407a-8c93-ec5cde2d323bRxCUI 1040031, 1040041, 1235247, 1297278, 1431235UNII O0P4I5851IUPC 0313668737301, 0313668465303, 0313668464306, 0313668466300, 0313668467307
- 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
N413668046730followed by a unit qualifier and the quantityPackage 13668-0467-30. 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: • 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 )]. Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults and adolescents (13 to 17 years) (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208055
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 120 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Inc | 43598-355 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 80 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-466 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-464 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-465 |
| Lurasidone Hydrochloride | Lurasidone hydrochloride 60 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-737 |