FDA.reportPublic FDA data

NDC 70518-3497-1 - CAPLYTA

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
70518-3497
Requested NDC
70518-3497-1
Package NDCs from labels
70518-3497-1, 70518-3497-0
Manufacturer
REMEDYREPACK INC.
Effective date
2024-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CAPLYTA - REMEDYREPACK INC.REMEDYREPACK INC.2024-01-12HUMAN PRESCRIPTION DRUG LABEL

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.

Matched openFDA labels page 1 of 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
CAPLYTALUMATEPERONEIntra-Cellular Therapies, Incdb730b06-6351-47fd-8183-e61e61bbead52025-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA209500
ndc (product): 72060-142
rxcui: 2275607
rxcui: 2607533
rxcui: 2607529
rxcui: 2607531
rxcui: 2607535
rxcui: 2275613
spl id: fa0963da-0db0-41f8-bb1a-153908a8bd77
spl set id: db730b06-6351-47fd-8183-e61e61bbead5
unii: 70BSQ12069
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
23f9eb49-00cc-63b9-e063-6394a90ae4d82ecc0f15-1d46-4b87-a6ae-aebb7b38bc732024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 2ecc0f15-1d46-4b87-a6ae-aebb7b38bc73
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.