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 2 of 9 · 163 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clear laxPOLYETHYLENE GLYCOL 3350HyVee Inc5bcf01d8-ddf3-4e64-8d3f-3526a51a58592026-07-02WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Safewaya70f41d0-0fad-4d15-8844-d60eabeb67322026-07-02WarningsExact identifier
unii: G2M7P15E5P
OGIVRITRASTUZUMAB-DKSTBiocon Biologics Inc.b6465b44-a6dd-f99c-d009-6851cf05169c2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761074
rxcui: 2179753
rxcui: 2179763
rxcui: 2179758
rxcui: 2179760
unii: P188ANX8CK
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
unii: 506T60A25R
KanjintiTRASTUZUMAB-ANNSAmgen, Inc9a94f5b2-b84e-4987-8ea1-c4346db5a5fa2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4e8b6a32-11ec-4419-9ec8-aaa1823899722026-06-19WarningsExact identifier
unii: G2M7P15E5P
GUNA-MATRIXASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE -Guna spafa9ed512-97dc-44a2-b32d-86ca8c2405322026-06-11WarningsExact identifier
unii: 1D5Q932XM6
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350PIONEER LIFE SCIENCES, LLC478f104a-0e50-479c-8722-a3f1eab686912026-06-11WarningsExact identifier
unii: G2M7P15E5P
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
unii: G2M7P15E5P
HerceptinTRASTUZUMABGenentech, Inc.492dbdb2-077e-4064-bff3-372d6af0a7a22026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
unii: G2M7P15E5P
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
unii: G2M7P15E5P
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
unii: 506T60A25R
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsExact identifier
unii: G2M7P15E5P
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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