FDA.reportPublic FDA data

NDC 78206-147-99 - Ontruzant

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
78206-147
Requested NDC
78206-147-99
Package NDCs from labels
78206-147-99, 78206-147-01
Manufacturer
Organon LLC | Samsung Bioepis Co., Ltd.
Effective date
2026-04-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ontruzant - Organon LLC | Samsung Bioepis Co., Ltd.Organon LLC | Samsung Bioepis Co., Ltd.2026-04-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-147-01Ontruzant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
78206-147-99Ontruzant1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-147ONTRUZANT (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ONTRUZANT KIT [ORGANON LLC]4Current NDC, Legacy NDC, 2 package rows20250316_ce2a2492-85e3-4b0a-872a-047f44e4203d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-147-01EA - Each78206-1479dcf0daa-4ad8-4eb9-9e79-c2a02754dd8b12021-10-08
78206-147-99EA - Each78206-147b663553a-6498-4fc7-ae61-a6114133ee6412023-03-13

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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
KanjintiTRASTUZUMAB-ANNSAmgen, Inc9a94f5b2-b84e-4987-8ea1-c4346db5a5fa2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
HerceptinTRASTUZUMABGenentech, Inc.492dbdb2-077e-4064-bff3-372d6af0a7a22026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
Herceptin HylectaTRASTUZUMAB AND HYALURONIDASE-OYSKGenentech, Inc.ebf30894-41cf-480c-8bc3-56f592a138132026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
PhesgoPERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXFGenentech, Inc.27dd5e6b-72cd-458d-a015-cf4dab5800da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
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
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
OntruzantTRASTUZUMABOrganon LLCce2a2492-85e3-4b0a-872a-047f44e4203d2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761100
ndc (package): 78206-148-01
ndc (package): 78206-147-01
ndc (package): 78206-191-99
ndc (package): 78206-149-89
ndc (package): 78206-147-99
ndc (product): 78206-147
ndc (product): 78206-148
ndc11 (package): 78206014799
rxcui: 2289227
rxcui: 2289232
rxcui: 2289234
rxcui: 2289237
spl id: 9b665849-a59e-4da6-ae51-36b3c885b85b
spl set id: ce2a2492-85e3-4b0a-872a-047f44e4203d
unii: P188ANX8CK
TrazimeraTRASTUZUMAB-QYYPPfizer Laboratories Div Pfizer Incb9c5e894-27d2-4245-a653-df986fed3c562026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-01-22WarningsExact identifier
unii: LKG8494WBH
L-Histidine High 7410L-HISTIDINE HIGHProfessional Complementary Health Formulas7eec7d23-236f-4770-9587-1bf602fd91c22026-01-08WarningsExact identifier
unii: 4QD397987E
HERZUMATRASTUZUMABCephalon, Inc.ae71c003-883a-4cd8-ad50-e8cc9a54e9712025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P188ANX8CK
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
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
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
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
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