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 3 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLCoupler LLC40187e83-1144-db0e-e063-6394a90a42df2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLMylan Institutional Inc.ad7d2f17-a4e8-4ebc-9baf-5983ac6267822025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC38f59751-4741-f588-e063-6294a90a65282025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLMethod Pharmaceuticals, LLC87f8773b-bf89-4f7e-bff4-8cad117d57762025-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
ndc (product): 58657-704
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
spl id: 38c21c0c-f6b3-adda-e063-6294a90a0ffd
spl set id: 87f8773b-bf89-4f7e-bff4-8cad117d5776
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack490efba9-70f1-46b8-9d62-2f96163e25df2025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLAmerican Health Packaging0ac0cc44-3924-447d-9051-f84c443123802025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLAmerican Health Packagingd62617da-c8ad-45da-8915-c59edc5558a52025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC325d169d-310d-4ada-e063-6294a90afbdd2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC315899f3-d510-10b0-e063-6294a90a2f3e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197754
unii: J6292F8L3D
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
HaloperidolHALOPERIDOLAmerican Health Packaging862d9bcd-aaaf-4b10-9013-f696f4cf95812025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC2ccbc964-a95c-d820-e063-6394a90a43072025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC2ccc2e26-de98-af81-e063-6394a90a040b2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLMajor Pharmaceuticals8a1014d0-d917-40b7-bddd-9ac97df91ef42025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLPAI Holdings, LLC dba PAI Pharmab488c106-f1ee-4b7b-8516-01162fb929f72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HaloperidolHALOPERIDOLMylan Pharmaceuticals Inc.c559b0b0-4087-d12a-e718-c18ccb6811e62025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepacke8977803-08a2-4ad0-87d5-63d81c98a5362024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLZydus Lifesciences Limited509d0eb2-b930-4836-9669-dbebf0ac40762024-11-30Exact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLLifestar Pharma LLC00bb61c8-db35-4c04-9ef7-47d447d2496b2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLAurobindo Pharma Limitedbf21633e-f37b-4017-a143-538eb005de2d2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
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.