FDA.reportPublic FDA data

NDC 63646-710-56 - Paliperidone Palmitate

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
63646-710
Requested NDC
63646-710-56
Package NDCs from labels
63646-710-56
Manufacturer
TOLMAR Inc.
Effective date
2026-03-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Paliperidone Palmitate Extended-Release Injectable SuspensionTOLMAR Inc.2026-03-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63646-700-56Paliperidone Palmitate1 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED1 mL156 mg in 1mL6
63646-710-56Paliperidone Palmitate1 in 1 CARTONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63646-710PALIPERIDONE PALMITATE KIT [TOLMAR INC.]52 package rows20240110_a08ab93b-0bac-42fd-8357-d10a49301b72.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.

Matched openFDA labels page 11 of 13 · 254 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: 7T1F30V5YH
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
unii: 7T1F30V5YH
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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