FDA.reportPublic FDA data

NDC 70518-3608-01 - 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
70518-3608
Requested NDC
70518-3608-01
Package NDCs from labels
70518-3608-0, 70518-3608-1, 70518-3608-3, 70518-3608-2, 70518-3608-01
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
70518-3608-0Haloperidol30 in 1 BLISTER PACKTABLET307
70518-3608-1Haloperidol30 in 1 BLISTER PACKTABLET307
70518-3608-2Haloperidol100 in 1 BOXTABLET1007
70518-3608-3Haloperidol1 in 1 POUCHTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3608HALOPERIDOL TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 4 package rows20240328_22598f07-501b-471a-b512-449d95e2301c.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 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLNCS HealthCare of KY, LLC dba Vangard Labs8743da03-67f1-4cb0-8159-45141cb5466e2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.a3afd19a-c340-4fad-8ddd-d712425153452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.22598f07-501b-471a-b512-449d95e2301c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
ndc (package): 70518-3608-2
ndc (package): 70518-3608-3
ndc (package): 70518-3608-0
ndc (package): 70518-3608-1
ndc (product): 70518-3608
ndc11 (package): 70518360801
rxcui: 310672
spl id: 4f5d4d03-9ae4-cacf-e063-6294a90a1eb0
spl set id: 22598f07-501b-471a-b512-449d95e2301c
unii: J6292F8L3D
HaloperidolHALOPERIDOLAiPing Pharmaceutical, Incbacc68ed-717b-477a-afa4-c45c182c617b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLMajor Pharmaceuticalse07f02d4-2768-4978-97ee-23ac52d0b8462026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 310672
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.eb69959d-5967-41ac-a222-ff4416869dfc2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.b5a6c54c-fb70-4132-90ae-7d75b5e9c9de2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310670
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLNovadoz Pharmaceuticals LLC3a474e06-fb00-40cb-aa3a-6edad43c2c0a2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.1e396020-899d-4f51-b71a-4982c503ca4f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.58fa9328-b1c7-407c-b215-9887db90cb942026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLInnogenix, Inc.2c26af24-5ed3-4eb7-8d29-d6a019320a702026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLCreekwood Pharmaceuticals LLC9763c044-7430-48f7-bf3e-da1c7c6839552025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLAdvagen Pharma Ltd8bfdc739-51b4-4914-9a60-923e837623072025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack966db55f-3f12-4653-9668-1beff85df0ab2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack5f4d945e-97f0-4afc-88d6-9b55ec2386862025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack9353117e-bd01-441a-b35f-fd1352c5df8c2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack457b8b71-8acf-47f1-93e5-1d353e53af102025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackea01b32e-5abe-455d-8813-cef101fa53f12025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack2cffe2ad-3dad-479e-a91a-b41c3dd05ce12025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071173
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLCardinal Health 107, LLC8ca14b79-6671-4e44-aa34-6564a92aa1972025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D

Reported adverse events (FAERS/openFDA)#

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