FDA.reportPublic FDA data

NDC 16729-282-46 - 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
16729-282
Requested NDC
16729-282-46
Package NDCs from labels
16729-282-10, 16729-282-01, 16729-282-16, 16729-282-46
Manufacturer
Accord Healthcare, Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ARIPIPRAZOLE - Accord Healthcare, Inc. | Intas Pharmaceuticals LimitedAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2025-10-06HUMAN PRESCRIPTION DRUG LABEL
ARIPIPRAZOLE - A-S Medication SolutionsA-S Medication Solutions2022-09-12HUMAN PRESCRIPTION DRUG LABEL
ARIPIPRAZOLE - REMEDYREPACK INC.REMEDYREPACK INC.2021-02-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-282-01ARIPIPRAZOLE100 in 1 BOTTLE, PLASTICTABLET10012
16729-282-10ARIPIPRAZOLE30 in 1 BOTTLE, PLASTICTABLET3012
16729-282-16ARIPIPRAZOLE500 in 1 BOTTLE, PLASTICTABLET50012
16729-282-46ARIPIPRAZOLE100 in 1 BLISTER PACKTABLET10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-282ARIPIPRAZOLE TABLET [ACCORD HEALTHCARE, INC.]11Current NDC, Legacy NDC, 4 package rows20231122_85cc7d25-414b-4b6f-a03a-48af908a16a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-282-01EA - Each16729-28238631795-2986-4044-9f02-ccce52e323b612017-03-06
16729-282-10EA - Each16729-282e42b9978-e7d0-4b2a-a5a5-438165ef348712017-03-06

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: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEMacleods Pharmaceuticals Limitedab4245a1-71f7-45be-a2ef-b0636ed3cc202025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
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: 349547
rxcui: 349553
rxcui: 602964
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: 349547
rxcui: 349553
rxcui: 602964
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
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
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.