FDA.reportPublic FDA data

NDC 83257-002 - 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
83257-002
Package NDCs from labels
83257-002-11
Manufacturer
Biocon Biologics Inc. | Biocon Biologics Limited
Effective date
2026-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OGIVRI - Biocon Biologics Inc. | Biocon Biologics LimitedBiocon Biologics Inc. | Biocon Biologics Limited2026-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-002OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON BIOLOGICS INC.]14Unmatched20241212_b6465b44-a6dd-f99c-d009-6851cf05169c.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 7 of 9 · 162 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350CHAIN DRUG MARKETING ASSOCIATION, INC.901a1918-87bb-47c2-a465-8c468c3a1ee52024-03-26WarningsExact identifier
unii: G2M7P15E5P
smoothlaxPOLYETHYLENE GLYCOL 3350Walgreen Companyaeb5c32c-443e-4ea3-8e96-fed38225fdf32024-03-12WarningsExact identifier
unii: G2M7P15E5P
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC02f81a86-bec5-4e8b-bddb-d463ae2ea9e92024-02-07WarningsExact identifier
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVELGM PHARMA SOLUTIONS, LLCd78bead5-ff19-4d45-9003-ec131f1f5a132024-01-17WarningsExact identifier
unii: G2M7P15E5P
CVS Maximum Strength LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDECVS Pharmacy Inc.e6aff579-affb-41bb-8e36-53ea484cb0c52023-11-26WarningsExact identifier
unii: LKG8494WBH
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsExact identifier
unii: G2M7P15E5P
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 4QD397987E
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: LKG8494WBH
unii: 506T60A25R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 506T60A25R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: LKG8494WBH
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
unii: LKG8494WBH
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 4QD397987E
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsExact identifier
unii: G2M7P15E5P
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsExact identifier
unii: G2M7P15E5P
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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