FDA.reportPublic FDA data

NDC 72578-106-30 - 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
72578-106
Requested NDC
72578-106-30
Package NDCs from labels
72578-106-06, 72578-106-30, 72578-106-78
Manufacturer
Viona Pharmaceuticals Inc. | SQUARE PHARMACEUTICALS PLC.
Effective date
2025-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aripiprazole - Viona Pharmaceuticals Inc. | SQUARE PHARMACEUTICALS PLC.Viona Pharmaceuticals Inc. | SQUARE PHARMACEUTICALS PLC.2025-01-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-106-06Aripiprazole30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3011
72578-106-30Aripiprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1011
72578-106-78Aripiprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-106ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [VIONA PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20250205_73c5e380-b7b1-4362-a827-71881574ff48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-106-06EA - Each72578-1065ef88e41-9de0-41da-93c0-0128ede358ef12022-09-12
72578-106-30EA - Each72578-1061f86a21c-41c3-49dc-b9a4-02b7c2e9bbb612025-06-13
72578-106-78EA - Each72578-106612c2bf6-9ebf-460f-874a-f656876841f712023-05-05

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 8 · 145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.b72c0cff-9f4d-42e2-b884-d06dea3e63782026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEApotex Corp.14910dae-da81-3d73-d0a4-e98d13917c692026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1d593ada-256d-4dec-9a26-2a6a67d972052026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.bc3fde41-2f24-44e2-815d-15fe55bd68b32026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.506fa28f-6f98-4632-bce8-72a9cb507c902026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.f713c38e-cc49-4243-96b9-32d5dbbcf9cb2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1ad7d167-1235-4c5c-8159-da8972240ede2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGDr. Reddy's Laboratories Inc394ea4a4-3991-4f98-b38f-56e9335d66b32026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 643022
rxcui: 643019
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited476b92f3-cf7b-4c09-ac67-6ed35e6811d52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 643022
rxcui: 643019
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALATLANTIC BIOLOGICALS CORP.042b725c-1c17-4cfb-80b2-c841226d795e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEUnit Dose Solutions, Inc.535f4fbd-b6a7-7611-e063-6294a90a5c432026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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