FDA.reportPublic FDA data

NDC 71288-502-01 - 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
71288-502
Requested NDC
71288-502-01
Package NDCs from labels
71288-502-01, 71288-502-02
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol Decanoate Injection (For Intramuscular Injection Only)REMEDYREPACK INC.2026-06-05HUMAN PRESCRIPTION DRUG LABEL
Haloperidol Decanoate - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-502-01Haloperidol Decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
71288-502-02Haloperidol Decanoate10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-502HALOPERIDOL DECANOATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20250426_14f40303-9604-4a30-8e86-8abaeb177ce1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-502-01ML - Milliliter71288-502bed017eb-2648-4548-a90e-e8239dcaedd512022-03-09
71288-502-02ML - Milliliter71288-50225559512-9489-496f-b43c-13561febf07b12022-03-09

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.2cdd9fca-afe5-4bfa-8db1-337beec13c6b2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719803
unii: AC20PJ4101
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Haloperidol DecanoateHALOPERIDOL DECANOATEGland Pharma Limited1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Pharmaceuticals USA Inc.6d2d7612-ad47-4ee7-a42c-945c976d947b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
Haloperidol DecanoateHALOPERIDOL DECANOATENorthStar RxLLCb83cb022-cfeb-4492-927b-0b461f7201d42026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719803
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATELifestar Pharma LLC8a96195e-97cd-4161-96e0-494a1636fa9c2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.4a3653df-84c7-46c2-b8fd-28c63cd2747a2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214507
ndc (package): 70518-3743-0
ndc (package): 70518-3743-1
ndc (product): 70518-3743
rxcui: 1719862
spl id: 53825865-95a6-9ee3-e063-6394a90aed36
spl set id: 4a3653df-84c7-46c2-b8fd-28c63cd2747a
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.80d51d2c-30e4-4eef-b184-0cebb30ca4292026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719803
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.9979e28f-2716-4788-8605-16f6edf158b52026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
Haloperidol DecanoateHALOPERIDOL DECANOATEMeitheal Pharmaceuticals Inc.14f40303-9604-4a30-8e86-8abaeb177ce12026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214507
ndc (package): 71288-502-02
ndc (package): 71288-503-01
ndc (package): 71288-503-02
ndc (package): 71288-504-05
ndc (package): 71288-502-01
ndc (product): 71288-504
ndc (product): 71288-502
ndc (product): 71288-503
ndc11 (package): 71288050201
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
spl id: 2cbc95d6-a15f-431f-9ff0-4827251bb767
spl set id: 14f40303-9604-4a30-8e86-8abaeb177ce1
unii: AC20PJ4101
Haloperidol decanoateHALOPERIDOL DECANOATEBluePoint Laboratories3d011250-a517-4c27-8ce3-d59d441ea61c2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.15b82169-882b-40ef-bbda-5adc3e7eb9302026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719803
unii: AC20PJ4101
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
unii: QX10HYY4QV
Haloperidol DecanoateHALOPERIDOL DECANOATEMylan Institutional LLC8ffac6fb-1702-40d6-b085-152d24673cbd2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
rxcui: 1719803
unii: AC20PJ4101
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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