FDA.reportPublic FDA data

NDC 72162-2635-02 - Fluphenazine 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
72162-2635
Requested NDC
72162-2635-02
Package NDCs from labels
72162-2635-2, 72162-2635-02
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluphenazine Decanoate - Bryant Ranch PrepackBryant Ranch Prepack2026-05-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2635-2Fluphenazine Decanoate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION5100
72162-2635-2Fluphenazine Decanoate1 in 1 CARTONINJECTION, SOLUTION1100

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 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine DecanoateFLUPHENAZINE DECANOATEPar Health USA, LLC970e6fde-9cc8-475b-8a9e-bde0579a72a72026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859824
unii: FMU62K1L3C
Fluphenazine DecanoateFLUPHENAZINE DECANOATEPar Health USA, LLCb580471f-44a1-4da0-96ad-2f537eabec3e2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859824
unii: FMU62K1L3C
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
Fluphenazine DecanoateFLUPHENAZINE DECANOATESagent Pharmaceuticals1842a678-c32b-4e81-998e-597fc370fb9e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859824
unii: FMU62K1L3C
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
Fluphenazine DecanoateFLUPHENAZINE DECANOATEBryant Ranch Prepack044f49f3-f980-4ef8-8beb-78412702cd9d2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215365
ndc (package): 72162-2635-2
ndc (product): 72162-2635
ndc11 (package): 72162263502
rxcui: 859824
spl id: 226377ed-4d32-4880-b283-1036c2d1d740
spl set id: 044f49f3-f980-4ef8-8beb-78412702cd9d
unii: FMU62K1L3C
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
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
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
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3 (CHOLECALCIFEROL) , CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIA CARBONICANutritional Specialties, Inc.4c86b348-5808-4d6d-b283-00ab37557fd72025-11-25WarningsExact identifier
unii: QX10HYY4QV
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
FLUPHENAZINE DECANOATEFLUPHENAZINE DECANOATEEugia US LLC1f532edc-1a2c-4221-80dd-1ac158dd3a722025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859824
unii: FMU62K1L3C
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.28c244ca-7a99-4750-9942-32fdf4d3dac92025-10-06WarningsExact identifier
unii: QX10HYY4QV
Fluphenazine DecanoateFLUPHENAZINE DECANOATENovadoz Pharmaceuticals LLC8d7ba627-cf3f-4b94-aee8-8b44cc9400be2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215365
ndc (product): 72205-100
rxcui: 859824
spl id: 10660418-e3a4-455b-bf84-add1f409ec16
spl set id: 8d7ba627-cf3f-4b94-aee8-8b44cc9400be
unii: FMU62K1L3C
Fluphenazine DecanoateFLUPHENAZINE DECANOATEHikma Pharmaceuticals USA Inc.1967dc24-f2a5-4095-baa9-a9d1c54103112025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859824
unii: FMU62K1L3C

Reported adverse events (FAERS/openFDA)#

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