NDC 16729-348-45 - lurasidone hydrochloride
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
- 16729-348
- Requested NDC
- 16729-348-45
- Package NDCs from labels
- 16729-348-10, 16729-348-15, 16729-348-16, 16729-348-17, 16729-348-45, 16729-348-46
- Manufacturer
- Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd
- Effective date
- 2025-10-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| lurasidone hydrochloride - Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | 2025-10-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-348-10 | lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 | |
| 16729-348-15 | lurasidone hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 | |
| 16729-348-16 | lurasidone hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 7 | |
| 16729-348-17 | lurasidone hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 7 | |
| 16729-348-45 | lurasidone hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 7 | |
| 16729-348-46 | lurasidone hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-348-10 | EA - Each | 16729-348 | 3767ceba-d6a9-40b8-916b-81c563c1c4ec | 1 | 2023-03-13 |
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 |
|---|---|---|---|---|---|---|
| bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05 | TITANIUM DIOXIDE AND ZINC OXIDE | Orveon Global US LLC | f1714e23-030c-4bd9-b9e7-111c3813ed34 | 2023-10-04 | Warnings | 15FIX9V2JP |
| bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23 | TITANIUM DIOXIDE AND ZINC OXIDE | Orveon Global US LLC | 828fe263-f223-45c3-9710-fd8d59ad56b1 | 2023-10-04 | Warnings | 15FIX9V2JP |
| bareMinerals Multi-Tasking SPF 20 Concealer Bisque | TITANIUM DIOXIDE | Orveon Global US LLC | d4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd | 2023-10-04 | Warnings | 15FIX9V2JP |
| BareMinerals Mineral Veil | TITANIUM DIOXIDE AND ZINC OXIDE | Orveon Global US LLC | 64b163dd-8a86-483f-8dab-80fa8740b12f | 2023-10-04 | Warnings | 15FIX9V2JP |
| DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 | TITANIUM DIOXIDE AND ZINC OXIDE | ORIGINS NATURAL RESOURCES INC. | 11248cab-c3a5-4e16-8280-9f70bb863cf7 | 2023-09-11 | Warnings | 15FIX9V2JP |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 15FIX9V2JP |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | 15FIX9V2JP |
| Anubis Barcelona Protective Line | ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE | ANUBIS COSMETICS SL | ec83846f-11c0-8f59-e053-2995a90ab9d2 | 2023-09-01 | Warnings | 15FIX9V2JP |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | 15FIX9V2JP |
| Mannitol | MANNITOL | B. Braun Medical Inc. | d12cc802-b538-4065-a264-f474ff3b3043 | 2023-08-15 | Warnings, Adverse reactions | 3OWL53L36A |
| Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade | SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE | Autumn Harp | fd6807e1-c8c0-b361-e053-6294a90aea0c | 2023-06-05 | Warnings | 15FIX9V2JP |
| Thinksport Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 77b63c0b-353b-4f5f-95c7-6f7eeab81471 | 2023-05-30 | Warnings | 15FIX9V2JP |
| Think Kids Mineral SPF 50 | ZINC OXIDE AND TITANIUM DIOXIDE | thinkOperations,LLC | 25c59820-a08d-4abe-87ae-a787ac8b2ac2 | 2023-05-30 | Warnings | 15FIX9V2JP |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | A-S Medication Solutions | 3cd2da15-4d51-4e5c-b683-1936dc19e234 | 2023-04-26 | Boxed warning, Warnings, Adverse reactions | ANDA208049 1235247 O0P4I5851I |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| Mineral Sunscreen SPF 50 | ZINC OXIDE TITANIUM DIOXIDE | Topiderm, Inc. | 3a637542-0f79-47ae-815d-84d0036c737a | 2023-02-13 | Warnings | 15FIX9V2JP |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 27f70e15-ee22-47ae-ba87-20e2b4a1a4d6 | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
| Lurasidone Hydrochloride | LURASIDONE HYDROCHLORIDE | Dr. Reddys Laboratories Inc | 2f22a0bd-94f3-53d7-717c-03da8e1a7e97 | 2023-01-19 | Boxed warning, Warnings, Adverse reactions | 1297278 O0P4I5851I |
| Josie Maran Argan Daily Moisturizer SPF47 | ZINC OXIDE, TITANIUM DIOXIDE | Autumn Harp, Inc. | 027821e6-db7d-4c03-956a-00313488ebc7 | 2023-01-14 | Boxed warning, Warnings | 15FIX9V2JP |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Ascend Laboratories, LLC | 36b6bacd-ac11-493b-a8a4-8dad448ed9d5 | 2023-01-06 | Boxed warning, Warnings, Adverse reactions | 1040041 1040031 1297278 1431235 1235247 O0P4I5851I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.