NDC 70518-3010-1 - Latuda
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 70518-3010
- Requested NDC
- 70518-3010-1
- Package NDCs from labels
- 70518-3010-1, 70518-3010-0
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2021-02-03
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Latuda - REMEDYREPACK INC. | REMEDYREPACK INC. | 2021-02-03 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3010 | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Legacy NDC | 20210204_2a26c9b9-4436-48b2-9c5d-d0af4500ad57.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| QR PAIN | ANALGESIC | MARYHELENE ENTERPRISES INC | 9984a510-30be-4013-e053-2995a90a841e | 2025-11-14 | Warnings | 3OWL53L36A |
| Mannitol | MANNITOL | ProPharma Distribution | 430669d7-9ad1-9a04-e063-6394a90ababb | 2025-11-07 | Warnings, Adverse reactions | 3OWL53L36A |
| Sorbitol-Mannitol | SORBITOL AND MANNITOL | ICU Medical Inc. | 5b44e248-4b7b-4777-954a-921c7b309944 | 2025-10-30 | Warnings, Adverse reactions | 3OWL53L36A |
| Mannitol | MANNITOL | ICU Medical Inc. | ba7bf864-8a4d-4262-8fd1-00174fa2f9d1 | 2025-10-24 | Warnings, Adverse reactions | 3OWL53L36A |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Accord Healthcare, Inc. | 7e11ec22-63c1-41a6-899c-4fe746f76bd0 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | a101e62e-dd1f-4add-8393-ba6d54adce06 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 1431235 O0P4I5851I |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 74f2429b-71df-47f0-9cb5-98685372a9b8 | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Major Pharmaceuticals | d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Osmitrol | MANNITOL | Baxter Healthcare Company | 0d914965-7001-45cb-ba51-d7c5964b05bc | 2025-08-26 | Warnings, Adverse reactions | 3OWL53L36A |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 4f969224-a9f0-4089-84d6-a15664ea7bfe | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | c80625bb-7857-4763-81fe-542b3448d84f | 2025-07-19 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Mannitol | MANNITOL | Henry Schein, Inc. | e2444db1-9dfe-451f-a33c-9b00786464d2 | 2025-05-20 | Warnings, Adverse reactions | 3OWL53L36A |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | Proficient Rx LP | fa9f0d28-c525-4a1e-acec-84c82e10b9a2 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Cipla USA, Inc. | 76c055aa-d96a-42e5-a670-1db63b9c1dd6 | 2025-03-01 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Exelan Pharmaceuticals Inc. | 4223e7f8-acbb-4738-9b77-ddc3405afb25 | 2025-03-01 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 1cc441b3-0a23-4c68-a90e-436030b7daf2 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Dr. Reddys Laboratories Inc | 9b512af1-98ab-1242-10e8-9534a002306e | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1431235 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Latuda | LURASIDONE HYDROCHLORIDE | Sumitomo Pharma America, Inc. | afad3051-9df2-4c54-9684-e8262a133af8 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | NDA200603 63402-308 1235249 1040041 1040043 1431237 1297357 1040031 1040036 1297278 1431235 1235247 7383b0e0-01e8-4778-96f0-6f2e0c9586ae afad3051-9df2-4c54-9684-e8262a133af8 O0P4I5851I |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | NorthStar RxLLC | 10a88607-0b5e-4707-b0cb-40c58a5c6774 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1431235 1235247 O0P4I5851I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.