FDA.reportPublic FDA data

NDC 72485-520-01 - 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
72485-520
Requested NDC
72485-520-01
Package NDCs from labels
72485-520-01, 72485-520-10
Manufacturer
Armas Pharmaceuticals Inc.
Effective date
2026-05-15
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 Rx OnlyArmas Pharmaceuticals Inc.2026-05-15Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-520-01Haloperidol Decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
72485-520-10Haloperidol Decanoate10 in 1 CARTONINJECTION101

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Haloperidol DecanoateHALOPERIDOL DECANOATEGland Pharma Limited1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
Haloperidol decanoateHALOPERIDOL DECANOATEZydus Pharmaceuticals USA Inc.6d2d7612-ad47-4ee7-a42c-945c976d947b2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
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
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATELifestar Pharma LLC8a96195e-97cd-4161-96e0-494a1636fa9c2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.4a3653df-84c7-46c2-b8fd-28c63cd2747a2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.530f440f-d4e8-423a-99a2-02d02e794ccb2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.80d51d2c-30e4-4eef-b184-0cebb30ca4292026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA219168
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEArmas Pharmaceuticals Inc.9979e28f-2716-4788-8605-16f6edf158b52026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA219168
ndc (package): 72485-520-10
ndc (package): 72485-520-01
ndc (product): 72485-520
ndc11 (package): 72485052001
rxcui: 1719862
spl id: f80ebd1c-e43e-4e6a-bbd0-96cfabafb548
spl set id: 9979e28f-2716-4788-8605-16f6edf158b5
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
rxcui: 1719862
unii: AC20PJ4101
Haloperidol decanoateHALOPERIDOL DECANOATEBluePoint Laboratories3d011250-a517-4c27-8ce3-d59d441ea61c2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
unii: AC20PJ4101
Haloperidol DecanoateHALOPERIDOL DECANOATEREMEDYREPACK INC.15b82169-882b-40ef-bbda-5adc3e7eb9302026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA219168
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
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-01-22WarningsExact identifier
unii: LKG8494WBH
Haloperidol DecanoateHALOPERIDOL DECANOATEMylan Institutional LLC8ffac6fb-1702-40d6-b085-152d24673cbd2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1719862
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
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH