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 20 of 28 · 552 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETIC ACIDACETIC ACIDChartwell RX, LLC2aaf3781-4f25-4799-8dcd-78d67e226ccc2024-03-26Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Calcium ChlorideCALCIUM CHLORIDEAmerican Regent, Inc.c5ef90b3-6ef0-410c-97d7-66a130b907412024-03-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
unii: 4550K0SC9B
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 339NCG44TV
Calcium ChlorideCALCIUM CHLORIDEInternational Medication Systems, Limited8295039b-2559-4626-90c8-6ac7e896e41a2024-03-01Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.b4985d9d-1aa0-4b36-bc98-6a5410ad9bad2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta9500f41-8041-d753-e053-2a95a90a6f3c2024-02-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a2024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992858
unii: R61ZEH7I1I
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst7447e8c6-c198-cd2d-e053-2a91aa0a38952024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
unii: R61ZEH7I1I
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Dysbio PlusACETICUM ACIDUM, ALOE, ARSENICUM ALBUM, BOTULINUM, BRUGIA MALAYI, CHININUM SULPHURICUM, CHOLERA NOSODE, CLOSTRIDIUM DIFFICILE, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, ECHINACEA (ANGUSTIFOLIA), HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, MERCURIUS CORROSIVUS, MORGAN GAERTNER, NUX VOMICA, PROTEUS (VULGARIS), SALMONELLA TYPHI NOSODEDeseret Biologicals, Inc.6864ab8e-3cf9-460e-b471-84ba3fb2efe02024-02-07WarningsExact identifier
unii: Q40Q9N063P
Dysbio PlusECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYIDeseret Biologicals, Inc.974f23e5-9062-42c1-9df3-12168edee1412024-02-07WarningsExact identifier
unii: Q40Q9N063P
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
unii: 339NCG44TV
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACIDCosette Pharmaceuticals, Inc.cef3713f-11f3-4723-9267-3d79855b49bf2024-02-02Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst75c43df8-24f4-7f26-e053-2a91aa0aa21b2024-01-29Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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