FDA.reportPublic FDA data

NDC 68001-657-41 - 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
68001-657
Requested NDC
68001-657-41
Package NDCs from labels
68001-657-41, 68001-657-56, 68001-657-51
Manufacturer
BluePoint Laboratories | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2026-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol decanoate - BluePoint Laboratories | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedBluePoint Laboratories | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-657-41Haloperidol decanoate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
68001-657-51Haloperidol decanoate3 in 1 CARTONINJECTION36
68001-657-56Haloperidol decanoate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-657-41ML - Milliliter68001-6574fe2cd4f-0ab4-49d8-ba8b-f6e27423985712025-08-11
68001-657-51ML - Milliliter68001-657c9311f6a-73e4-4388-88a0-4ac0650bc70212025-08-11
68001-657-56ML - Milliliter68001-6570ebe206d-713c-4181-9037-dc9a29c2732812025-08-11

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
application number: ANDA211180
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
rxcui: 1719862
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
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
unii: AC20PJ4101
Haloperidol decanoateHALOPERIDOL DECANOATEBluePoint Laboratories3d011250-a517-4c27-8ce3-d59d441ea61c2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211180
ndc (package): 68001-657-41
ndc (package): 68001-659-41
ndc (package): 68001-657-51
ndc (package): 68001-658-52
ndc (package): 68001-658-41
ndc (package): 68001-657-56
ndc (product): 68001-658
ndc (product): 68001-657
ndc (product): 68001-659
ndc11 (package): 68001065741
rxcui: 1719862
rxcui: 1719803
rxcui: 859871
spl id: 4dc563ca-3dbe-0ca5-e063-6394a90ad276
spl set id: 3d011250-a517-4c27-8ce3-d59d441ea61c
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.