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 4 of 14 · 265 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MERC CORRALUMINA, BRYONIA, COLOCYNTHIS, CHINA OFF, LYCOPODIUM, THUJA OCC, NUX VOMBM Private Limited3b29d70d-f291-dad2-e063-6294a90a07f52026-02-12WarningsExact identifier
unii: LMI26O6933
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.2bc00231-c2e7-4b9d-93a1-fb796fd8d5912026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1e8d889e-126b-4627-a2cc-34f2d35a5d672026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1ef9e44f-5672-47c2-97e9-286e1b84417d2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack4bda6f17-d87c-4009-b329-99275c56106f2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfb40b669-4e37-4087-8fb1-3ac1405436022026-01-27Boxed 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.