FDA.reportPublic FDA data

NDC 70069-031-01 - HALOPERIDOL DECANOATE

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
70069-031
Requested NDC
70069-031-01
Package NDCs from labels
70069-031-01, 70069-031-05
Manufacturer
Somerset Therapeutics, LLC | Somerset Therapeutics Limited
Effective date
2023-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HALOPERIDOL - Somerset Therapeutics, LLC | Somerset Therapeutics LimitedSomerset Therapeutics, LLC | Somerset Therapeutics Limited2023-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-031-01HALOPERIDOL DECANOATE1 mL in 1 AMPULEINJECTION119
70069-031-05HALOPERIDOL DECANOATE5 in 1 CARTONINJECTION519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-031HALOPERIDOL DECANOATE INJECTION [SOMERSET THERAPEUTICS, LLC]19Current NDC, Legacy NDC, 2 package rows20231219_f2bff27f-929f-4f7d-b3eb-084ebc2a885f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-031-01ML - Milliliter70069-0316fcb61cf-f6a8-4711-b570-e648e284b70d12018-11-06
70069-031-05ML - Milliliter70069-031d56c919d-80c6-4b8a-9d96-96d93899385512018-11-06

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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
haloperidol decanoateHALOPERIDOL DECANOATESagent Pharmaceuticalsb3167043-585f-482f-b8a7-591bc2721bd32024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCf2bff27f-929f-4f7d-b3eb-084ebc2a885f2023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209101
ndc (package): 70069-383-05
ndc (package): 70069-383-10
ndc (package): 70069-383-01
ndc (package): 70069-382-01
ndc (package): 70069-381-10
ndc (package): 70069-031-05
ndc (package): 70069-031-01
ndc (package): 70069-384-01
ndc (package): 70069-030-03
ndc (package): 70069-381-01
ndc (package): 70069-384-05
ndc (package): 70069-382-05
ndc (package): 70069-030-05
ndc (product): 70069-031
ndc (product): 70069-030
ndc (product): 70069-381
ndc (product): 70069-382
ndc (product): 70069-383
ndc (product): 70069-384
ndc11 (package): 70069003101
rxcui: 859867
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
spl id: f6d888a0-65a7-4073-8671-b00b4bfaff4c
spl set id: f2bff27f-929f-4f7d-b3eb-084ebc2a885f
unii: AC20PJ4101
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: QX10HYY4QV
HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEBluePoint Laboratoriesf2d14406-2ad4-4c5b-9c24-a026f27b415d2023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209101
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: LKG8494WBH
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Lifesciences Limitedd21796e5-9f29-4c0a-8eed-70aeb9f0e5e92023-09-01Exact identifier
rxcui: 859867
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEFresenius Kabi USA, LLC262456c4-47e5-4713-8379-844f8f5874952021-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEFresenius Kabi USA, LLCca9896e0-fb2e-46a4-8700-20d144c147642021-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859867
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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