FDA.reportPublic FDA data

NDC 71872-7285-01 - Promethazine Hydrochloride

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
71872-7285
Requested NDC
71872-7285-01
Package NDCs from labels
71872-7285-1, 71872-7285-01
Manufacturer
Medical Purchasing Solutions, LLC
Effective date
2023-05-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7285-1Promethazine Hydrochloride1 in 1 BAGINJECTION12
71872-7285-1Promethazine Hydrochloride1 mL in 1 AMPULEINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7285PROMETHAZINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230504_dc8b50de-e4f6-607f-e053-2995a90a2902.zip

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 19 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8749824b-6d66-430d-e053-2995a90a2db82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7e5715cf-056f-4095-e053-2991aa0ad3e52024-06-12Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4bf3912c-8339-401e-9711-dad6acf15f112024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
rxcui: 992858
unii: R61ZEH7I1I
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Liver DrainageCHELIDONIUM MAJUS, CARDUUS MARIANUS, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, BERBERIS VULGARIS, RAPHANUS SATIVUS, VISCUM ALBUM, CHROMIUM PICOLINATE, COBALT GLUCONATE, COPPER GLUCONATE, MAGNESIUM GLUCONATE, NATRUM SULPHURICUM, PTELEA TRIFOLIATE, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, CARBOLICUM ACIDUM, CICHORIUM INTYBUS, FLOS, GALLBLADDER (SUIS), HEPAR SUIS, NUX VOMICA, PANCREAS SUIS, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, PICRORHIZA KURROADeseret Biologicals, Inc.1857dee7-4227-4fa3-9d70-1f02264392902024-05-29WarningsExact identifier
unii: 339NCG44TV
Liver DrainageBERBERIS VULGARIS, CARBOLICUM ACIDUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHROMIUM PICOLINATE, CICHORIUM INTYBUS, FLOS, COBALT GLUCONATE, COPPER GLUCONATE, GALLBLADDER (SUIS), HEPAR SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM SULPHURICUM, NUX VOMICA, PANCREAS SUIS, PICRORHIZA KURROA, PTELEA TRIFOLIATE, RAPHANUS SATIVUS, SARCOLACTICUM ACIDUM, SCHISANDRA CHINENSIS, SULPHUR, TARAXACUM OFFICINALE, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, VISCUM ALBUMDeseret Biologicals, Inc.bd3151b4-fe34-4288-b8e0-ba8850f4b39b2024-05-28WarningsExact identifier
unii: 339NCG44TV
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.481866da-a712-48a5-853f-8e84aacaab6d2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
rxcui: 992858
unii: R61ZEH7I1I
GI DistressACETICUM ACIDUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, CROTON TIGLIUM, ECHINACEA (ANGUSTIFOLIA), FERRUM METALLICUM, GAMBOGIA, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NATRUM PHOSPHORICUM, NUX VOMICA, PROTEUS (MIRABILIS), RICINUS COMMUNIS, VERATRUM ALBUMDeseret Biologicals, Inc.40df69fa-92ae-4f26-8664-36955cf395c52024-05-13WarningsExact identifier
unii: Q40Q9N063P
GI DistressECHINACEA (ANGUSTIFOLIA), NATRUM PHOSPHORICUM, COLCHICUM AUTUMNALE, ARSENICUM ALBUM, COLOCYNTHIS, CROTON TIGLIUM, GAMBOGIA, ACETICUM ACIDUM, ANTIMONIUM CRUDUM, BISMUTHUM SUBNITRICUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, IRIS VERSICOLOR, LAC DEFLORATUM, MERCURIUS VIVUS, NUX VOMICA, RICINUS COMMUNIS, VERATRUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (MIRABILIS)Deseret Biologicals, Inc.056ac695-82d3-4164-9123-79520b5deecc2024-05-08WarningsExact identifier
unii: Q40Q9N063P
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
unii: 339NCG44TV
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICA, URANIUM NITRICUMDeseret Biologicals, Inc.39445c53-e661-4203-a4fb-a071075ac0e22024-04-26WarningsExact identifier
unii: Q40Q9N063P
unii: 339NCG44TV
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: Q40Q9N063P
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEBryant Ranch Prepackdf2c24ba-1c88-4ec3-b2a1-801358ec645c2024-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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