Prescription drug · ANDA
Lurasidone Hydrochloride NDC 60687-769
Lurasidone hydrochloride 60 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-769-94 | 60687076994 | 20 BLISTER PACK in 1 CARTON (60687-769-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-769-11)Marketed from May 9, 2023 |
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 — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212244
- Marketing start
- Listing expires
- Identifiers
- Product ID 60687-769_2abe376d-e980-af98-e063-6394a90ac3efSPL ID 2abe376d-e980-af98-e063-6394a90ac3efSPL set ID b83e1015-8016-4c7c-8239-8dba3a882e46RxCUI 1040031, 1040041, 1235247, 1431235UNII 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
N460687076994followed by a unit qualifier and the quantityPackage 60687-0769-94. 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 associated …
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 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 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4260 |
| 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 |