FDA.reportPublic FDA data

NDC 60505-0404-05 - aripiprazole

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
60505-0404
Requested NDC
60505-0404-05
Package NDCs from labels
60505-0404-5, 60505-0404-05
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
aripiprazole - Apotex Corp. | Apotex Inc.Apotex Corp. | Apotex Inc.2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0404-5aripiprazole150 mL in 1 BOTTLESOLUTION15016
60505-0404-5aripiprazole1 in 1 CARTONSOLUTION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0404ARIPIPRAZOLE SOLUTION [APOTEX CORP.]15Current NDC, Legacy NDC, 2 package rows20250412_14910dae-da81-3d73-d0a4-e98d13917c69.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0404-5ML - Milliliter60505-0404555da0fa-3d00-4fbf-8cf6-ca3905a7109a12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
Malic AcidINACTIVE INGREDIENT817L1N4CKPARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
OrangeINACTIVE INGREDIENT5EVU04N5QUARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
SUCROSEINACTIVE INGREDIENTC151H8M554ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RARIPIPRAZOLE SOLUTION [APOTEX CORP.]2

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 39 · 761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.b72c0cff-9f4d-42e2-b884-d06dea3e63782026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
aripiprazoleARIPIPRAZOLEApotex Corp.14910dae-da81-3d73-d0a4-e98d13917c692026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204094
ndc (package): 60505-0404-5
ndc (product): 60505-0404
ndc11 (package): 60505040405
rxcui: 485496
spl id: 47ebed0d-6481-a04f-7f22-f3716424fd39
spl set id: 14910dae-da81-3d73-d0a4-e98d13917c69
unii: 82VFR53I78
Kroger Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDKROGER COMPANYfb7326db-3512-45ee-9a9b-48f3ebd8d0c52026-09-02WarningsExact identifier
unii: 6YSS42VSEV
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
CVS Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDCVS PHARMACYf6f7568b-3887-434d-9403-a3ecdc591bbc2026-08-17WarningsExact identifier
unii: 6YSS42VSEV
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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