FDA.reportPublic FDA data

NDC 70518-3587-2 - Haloperidol

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
70518-3587
Requested NDC
70518-3587-2
Package NDCs from labels
70518-3587-0, 70518-3587-2, 70518-3587-1
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol Tablets, USPREMEDYREPACK INC.2026-04-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3587-0Haloperidol30 in 1 BLISTER PACKTABLET306
70518-3587-1Haloperidol100 in 1 BOXTABLET1006
70518-3587-2Haloperidol1 in 1 POUCHTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3587HALOPERIDOL TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20240116_a3afd19a-c340-4fad-8ddd-d71242515345.zip

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLZydus Pharmaceuticals USA Inc.54502f78-7244-454a-9171-4e73127f14562024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLMarlex Pharmaceuticals, Inc.e7a61604-741f-2d3b-e053-2995a90a62fc2024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackd9d0e530-02cd-4631-b3c8-cf6de521fd5b2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackdf340d75-7387-4084-9d76-167283ee74622024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackd896823a-fb08-4777-a1f1-cef85fc8d96c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackf1c56d0d-87d3-40ef-9578-0d99fbae12fe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack88031df0-90bd-4444-9503-1b4612e3856b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackb9e8f5f2-6d59-4a2c-8ccf-88bb58753f602024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepacka8e9d675-135c-4b5d-91d0-1ef0d295535c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackf20769bc-98a3-419a-ba36-2e9737050cd92024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack33dca652-c60c-44e0-9303-ea55a431fdcd2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackc3b35c6c-e339-439a-b75f-dd645e08a9592024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack1171bd60-7105-4b70-a24c-f2bc8c52a8c02024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepacka79c12f2-cf98-4337-8b6a-7b9ef2afa9d52024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLAmici Pharmaceuticals, LLC9a9e20dd-646a-4fe9-a345-1b5bda8e77752022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D

Reported adverse events (FAERS/openFDA)#

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