FDA.reportPublic FDA data

NDC 67457-846 - OGIVRI

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
67457-846
Package NDCs from labels
67457-846-20
Manufacturer
Mylan Institutional LLC
Effective date
2021-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OGIVRI - Mylan Institutional LLCMylan Institutional LLC2021-02-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-846OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]15Unmatched20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.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 4 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
unii: 506T60A25R
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350ANI Pharmaceuticals, Inc.1afff730-b2d3-4e01-8403-97f2ecef3a742025-12-10WarningsExact identifier
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
unii: G2M7P15E5P
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
unii: G2M7P15E5P
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsExact identifier
unii: G2M7P15E5P
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
unii: G2M7P15E5P
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350 Powder for SolutionPOLYETHYLENE GLYCOL, UNSPECIFIEDVALLEY MEDICAL PRODUCTS, LLCae595e97-6d29-44f8-a647-fcd54fcda5b12025-10-27WarningsExact identifier
unii: G2M7P15E5P
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsExact identifier
unii: G2M7P15E5P
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsExact identifier
unii: G2M7P15E5P
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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