FDA.reportPublic FDA data

NDC 71872-7077-01 - 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
71872-7077
Requested NDC
71872-7077-01
Package NDCs from labels
71872-7077-1, 71872-7077-01
Manufacturer
Medical Purchasing Solutions, LLC
Effective date
2023-05-23
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, LLC2023-05-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7077-1Promethazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION13
71872-7077-1Promethazine Hydrochloride1 in 1 BAGINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7077PROMETHAZINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]3Current NDC, Legacy NDC, 2 package rows20230524_677b5fc5-94be-638b-e053-2991aa0a7f97.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 18 of 28 · 552 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM ACETATESODIUM ACETATEFresenius Kabi USA, LLCd7fabf08-d4e0-4bb5-8416-2e8ffe27c04b2024-10-11Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: 339NCG44TV
FNGBERBERIS VULGARIS, COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, TABEBUIA IMPETIGINOSA, THYMUS (SUIS), FORMALINUM, CARBOLICUM ACIDUM, FERRUM METALLICUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRASTENSIS), SELENIUM METALLICUM, ZINCUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, METHYLCOBALAMIN, SARCOLACTICUM ACIDUM, MUCOR RACEMOSUS, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER,Deseret Biologicals, Inc.fd32287e-af1a-45d3-b82a-5cc004db6bc92024-09-27WarningsExact identifier
unii: 339NCG44TV
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.84899861-8fed-536d-e053-2991aa0a42b22024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsa4fbc2d8-19b3-4556-b0b9-6e7a14cd4c362024-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepack07914b6e-c40f-44be-a1db-8724c70f99b62024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackea490539-007b-47b1-bef9-22de02ae7c642024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacka4b3da5b-1129-43c2-bf22-3a29c3fae1162024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.7470a1ed-bc00-cb52-e053-2a91aa0a5c7d2024-07-15Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
unii: 339NCG44TV
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
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
ndc (product): 0641-0928
rxcui: 992460
rxcui: 992858
spl id: 9f14d3f5-ad01-44b5-a2b7-16ed5f501f87
spl set id: 4bf3912c-8339-401e-9711-dad6acf15f11
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

Reported adverse events (FAERS/openFDA)#

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