FDA.reportPublic FDA data

NDC 43598-391 - 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
43598-391
Package NDCs from labels
43598-391-50
Manufacturer
Dr.Reddy's Laboratories Inc | Gland Pharma Ltd
Effective date
2018-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Melphalan Hydrochloride - Dr.Reddy's Laboratories Inc | Gland Pharma LtdDr.Reddy's Laboratories Inc | Gland Pharma Ltd2018-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-391MELPHALAN HYDROCHLORIDE KIT [DR.REDDY'S LABORATORIES INC]8Unmatched20210717_d4705154-3050-1a5c-950f-e24b51487401.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 156 of 156 · 3,113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEDr.Reddy's Laboratories Incd4705154-3050-1a5c-950f-e24b514874012018-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203655
ndc (package): 43598-393-35
ndc (package): 43598-392-48
ndc (package): 43598-391-50
ndc (product): 43598-392
rxcui: 311487
spl id: 7f4cc8ff-4b1c-86d8-ea19-0bab41202737
spl set id: d4705154-3050-1a5c-950f-e24b51487401
Discount Drug Mart Vitamin E Hand SanitizerETHYL ALCOHOLDiscount Drug Mart8ce10d80-baab-4647-9abb-ebfd9009a1722018-02-09WarningsExact identifier
unii: 3K9958V90M
KidzStuff Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7ecf92e5-0ad6-41f0-bd02-2f79acb2b7222018-01-17WarningsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholALCOHOLZee Medical8dc593e3-1163-4978-a39c-a9b29074699a2017-12-11WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Alcohol WipesALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.14dbe9dc-2504-4181-9565-5fa7c1a9c3772017-10-09WarningsExact identifier
unii: 3K9958V90M
Freeman Packaging Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.9827418a-3ab6-447b-8f8a-9eacb56d3a892017-10-09WarningsExact identifier
unii: 3K9958V90M
ONID WipeETHANOLONID Technology Corp83d8b8b6-6257-4553-9441-901bb02c3d602017-06-28Exact identifier
unii: 3K9958V90M
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS Hand SanitizerALCOHOLCVSd0081c50-c0d2-436a-ba83-5d1982ae64b72015-08-17WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLSafetec of America, Inc.f9e30645-491b-4f54-acfd-f863ee2356072013-08-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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