FDA.reportPublic FDA data

NDC 83634-201 - 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
83634-201
Package NDCs from labels
83634-201-10
Manufacturer
Avenacy Inc.
Effective date
2023-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Melphalan Hydrochloride for Injection (For Intravenous Infusion)Avenacy Inc.2023-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-201MELPHALAN HYDROCHLORIDE KIT [AVENACY INC.]1Unmatched20231218_8edd78a9-d762-4578-a610-28d6595f4bf3.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 140 of 157 · 3,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Sanitizing wipes with aloe Grapefruit GroveALCOHOLThe Honest Companyfaa3690b-ce0d-43d4-9e5c-f2ce77daabe72023-12-19WarningsExact identifier
unii: 3K9958V90M
Sanitizing Wipes Fragrance FreeALCOHOLThe Honest Company0ce3e7ee-aa50-16bc-e063-6294a90a527d2023-12-19WarningsExact identifier
unii: 3K9958V90M
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
unii: 3K9958V90M
Sunmark Iodides TinctureETHYL ALCOHOLStrategic Sourcing Services LLC5e227f79-fca7-4633-97ea-61da4060fe922023-12-19WarningsExact identifier
unii: 3K9958V90M
DDM Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLDiscount Drug Mart5d538c8e-bf87-d85c-e053-2991aa0af7292023-12-19WarningsExact identifier
unii: 3K9958V90M
DDM Decolorized IodineETHYL ALCOHOLDiscount Drug Mart5d570ea7-ab08-54b7-e053-2991aa0a7a832023-12-19WarningsExact identifier
unii: 3K9958V90M
Top Care Decolorized IodineETHYL ALCOHOLTOPCO ASSOCIATES LLC5d6bdc17-5c3a-7dec-e053-2991aa0aa4502023-12-18WarningsExact identifier
unii: 3K9958V90M
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEAvenacy Inc.8edd78a9-d762-4578-a610-28d6595f4bf32023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211463
ndc (package): 83634-200-15
ndc (package): 83634-202-61
ndc (package): 83634-201-10
ndc (product): 83634-202
rxcui: 311487
spl id: 47da36c6-67e2-44c7-93d8-4f236abb73e7
spl set id: 8edd78a9-d762-4578-a610-28d6595f4bf3
Ethyl Rubbing AlcoholALCOHOLHumco Holding Group, Inc.829f3e16-7a9b-4da7-87d2-f58254bda7212023-12-15WarningsExact identifier
unii: 3K9958V90M
Humco Iodides TinctureETHYL ALCOHOLHumco Holding Group, Inc.d230e3a2-1cde-44a9-82c3-3dc5474b3a722023-12-15WarningsExact identifier
unii: 3K9958V90M
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
unii: 3K9958V90M
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
unii: 3K9958V90M
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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