FDA.reportPublic FDA data

NDC 59148-0010-35 - ABILIFY

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
59148-0010
Requested NDC
59148-0010-35
Package NDCs from labels
59148-0010-35
Manufacturer
Rebel Distributors Corp. | Rebel Distributors
Effective date
2010-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ABILIFY - Rebel Distributors Corp. | Rebel DistributorsRebel Distributors Corp. | Rebel Distributors2010-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1

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 8 of 14 · 265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abilify AsimtufiiARIPIPRAZOLEOtsuka America Pharmaceutical, Incda4c07fd-1130-4341-bb44-63acfa4162be2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLETorrent Pharmaceuticals Limited3988e66f-339c-451e-9f8a-9d0c0a2a381b2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEMacleods Pharmaceuticals Limitedab4245a1-71f7-45be-a2ef-b0636ed3cc202025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
Bestmade Natural Products AluminaALUMINABestmade Natural Products2f824dae-5cd2-5ac7-e063-6394a90aa9852025-03-04WarningsExact identifier
unii: LMI26O6933
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC7f272100-e02f-4a16-bb39-a2bf844db4f92025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC06dda03f-8481-46d6-af02-4f51e1a3a0652025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEUnichem Pharmaceuticals (USA), Inc.349b8a7b-5ada-4f5c-a269-a86806c6b5202025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALCamber Pharmaceuticals, Inc.da47ad78-e62c-4bf3-9b53-d8cc246bcfb62025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.de2dc5fd-ecb4-4445-9cfb-10e64fe3269d2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: LMI26O6933
OPIPZAARIPIPRAZOLECarwin Pharmaceutical Associates, LLCb47ede68-8942-4432-af7e-57afc14b2ba42025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021436
ndc11 (package): 59148001035
rxcui: 352308
rxcui: 352309
rxcui: 349553
rxcui: 349545
rxcui: 352307
rxcui: 349490
rxcui: 402131
rxcui: 404602
unii: 82VFR53I78
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: LMI26O6933
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: LMI26O6933
AripiprazoleARIPIPRAZOLELannett Company, Inc.e7292c4c-e332-4ed4-9086-f130d223b6ae2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Bestmade Natural Products BM40ALUMINAD7, CAUSTICUMD8, GELSEMIUMD3, MOSCHUSD14, PLUMBUMD9, SECALE CORND4, ZINCUM ACETD9Bestmade Natural Productsef43f183-1be9-4c7e-e053-2a95a90a4b062025-01-23WarningsExact identifier
unii: LMI26O6933
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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