FDA.reportPublic FDA data

NDC 10139-319 - Melphalan 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
10139-319
Package NDCs from labels
10139-319-10
Manufacturer
GeneraMedix Inc. | Coldstream Laboratories Inc
Effective date
2009-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Melphalan Hydrochloride - GeneraMedix Inc. | Coldstream Laboratories IncGeneraMedix Inc. | Coldstream Laboratories Inc2009-10-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10139-319-10Melphalan Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION10 mL50 mg in 10mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10139-319MELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2Unmatched20091120_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MELPHALAN HYDROCHLORIDEACTIVE INGREDIENT1VXP4V453TMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2
MELPHALANACTIVE MOIETYQ41OR9510PMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMELPHALAN HYDROCHLORIDE KIT [GENERAMEDIX INC.]2

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 155 of 156 · 3,118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.d99b3865-e0f0-482a-9ec6-da642e5104ea2021-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEMylan Institutional LLCa8bf1877-fd06-4ef6-b82d-fe0ff1956bde2020-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEFosun Pharma USA Inc54712714-744d-4deb-83b2-694da49a92722019-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEGland Pharma Limitedea7fbf4e-4980-4bb4-bac9-99eb6f633ba02019-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.461859ad-7833-47ae-90da-1dea5f26cc4b2018-12-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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