FDA.reportPublic FDA data

NDC 65219-383-08 - BL-C Kit

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
65219-383
Requested NDC
65219-383-08
Package NDCs from labels
65219-383-05, 65219-383-02, 65219-383-04, 65219-383-10, 65219-383-06, 65219-383-50, 65219-383-08, 65219-383-70
Manufacturer
Asclemed USA, Inc.
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BL-C Kit - Asclemed USA, Inc.Asclemed USA, Inc.2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Iodixanol - FRESENIUS KABI USA, LLCFRESENIUS KABI USA, LLC2023-07-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-383-02Iodixanol50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION505
65219-383-04Iodixanol100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1005
65219-383-05Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-06Iodixanol150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1505
65219-383-08Iodixanol200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION2005
65219-383-10Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-50Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-70Iodixanol10 in 1 BOXINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-383IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 8 package rows20230803_0fe89ea2-04f7-46c5-9c35-220d8c144a95.zip
65219-383BL-C KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1Current NDC, Legacy NDC20250102_798f3bc6-d976-49a6-87a2-fd30c784fc50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-383-02ML - Milliliter65219-3839c8f92e1-1d2f-45a3-b106-e667351a3b5912022-08-04
65219-383-04ML - Milliliter65219-38318a8eb9c-3a0e-48f6-923e-b2c69ea83fc612022-08-04
65219-383-05ML - Milliliter65219-38303116f77-4e6e-4156-aa55-494a6947b13312022-08-04
65219-383-06ML - Milliliter65219-383cf036647-b8a2-40df-8d73-8674219ed3b812022-08-04
65219-383-08ML - Milliliter65219-3831720119c-54ab-4428-b510-7259878bd32212022-08-04
65219-383-10ML - Milliliter65219-3837c22f47f-2fea-465a-bbe3-9bfa10568efc12022-08-04
65219-383-50ML - Milliliter65219-38391e05960-b2b9-4287-86cb-6c37c9196f4112022-08-04
65219-383-70ML - Milliliter65219-3831dafed13-5210-487e-8d9e-21ff60c356b112022-08-04

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 1 of 275 · 5,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
application number: ANDA203082
rxcui: 1737761
unii: V13007Z41A
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
North Woods Derma Foam Hand SanitizerBENZALKONIUM CHLORIDESuperior Chemical Corporationad51a175-2b91-fd14-e053-2995a90ad54d2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Foaming Hand SanitizerBENZALKONIUM CHLORIDEBetco Corporation, Ltd.7e038b0a-4813-4f4b-ad66-0584d75a064f2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
application number: M003
unii: F5UM2KM3W7
unii: V13007Z41A
Ultra Blue Antibacterial Foaming Skin CleanserBENZALKONIUM CHLORIDEBetco Corporation, Ltdaa8f5b05-882d-d05a-e053-2995a90abaea2026-09-09WarningsExact identifier
unii: F5UM2KM3W7
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsExact identifier
application number: M003
rxcui: 797730
unii: 85H0HZU99M
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
unii: ND2M416302
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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