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 9 of 14 · 265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEDirect_Rxf81d9b82-5879-3c0a-e053-6294a90ac23e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfacdb9a9-612f-e59a-e053-6394a90a1fa72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfcea91c3-e428-8991-e053-6394a90a099d2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
Bestmade Natural Products BM6AGRIMONIAD6, ALUMINAD12, HYDRASTISD4, KALI BICHD6, PULSATILLAD5, SEPIAD4Bestmade Natural Productsec034f53-5577-5985-e053-2995a90a67292025-01-22WarningsExact identifier
unii: LMI26O6933
Bestmade Natural Products BM21ALUMINAD5, BRYONIAD5, COLOCYNTHISD6, GRAPHITED10, HYDRASTISD3, LYCOPODIUMD4, MAG MURD12, NUX VOMICAD5,OPIUMD30, PLUMBUMD7Bestmade Natural Productsedc29044-5fae-7916-e053-2995a90a59882025-01-22WarningsExact identifier
unii: LMI26O6933
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEBionpharma Inc.720bc395-777d-4e5d-9571-aad5827dbf6d2025-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEViona Pharmaceuticals Inc.73c5e380-b7b1-4362-a827-71881574ff482025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: LMI26O6933
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: LMI26O6933
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: LMI26O6933
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.34127431-6ad7-402f-bc22-1429c55d921c2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.4894031e-639e-49d8-927a-76d684bf66552025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.faa3032b-d9a1-45dd-88be-abb432223f132025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPrefferred Pharmaceuticals Inc.fbb3ac69-8dba-42df-8d6d-ef3d79241edb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: LMI26O6933
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: LMI26O6933
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.27874fe2-3fd6-002d-e063-6294a90a4cd72024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGScieGen Pharmaceuticals Inc4bcfd5a7-bec7-4426-9314-17daaf715cad2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
rxcui: 349490
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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