FDA.reportPublic FDA data

NDC 78206-183-99 - Hadlima

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
78206-183
Requested NDC
78206-183-99
Package NDCs from labels
78206-183-99, 78206-183-01
Manufacturer
Organon LLC | Samsung Bioepis Co., Ltd.
Effective date
2025-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hadlima - Organon LLC | Samsung Bioepis Co., Ltd.Organon LLC | Samsung Bioepis Co., Ltd.2025-10-17HUMAN PRESCRIPTION DRUG LABEL
HADLIMA - A-S Medication SolutionsA-S Medication Solutions2023-10-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-183-01Hadlima2 in 1 CARTONSOLUTION213
78206-183-99Hadlima1 in 1 CARTONSOLUTION113
78206-183-99Hadlima0.8 mL in 1 SYRINGESOLUTION0.813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-183HADLIMA (ADALIMUMAB-BWWD) SOLUTION [ORGANON LLC]10Current NDC, 3 package rows20240713_4774a951-3ce8-43b6-80b1-e6b23752aae6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-183-01ML - Milliliter78206-1838aff14d2-1bca-475e-a400-ea5724203aa612023-08-08
78206-183-99ML - Milliliter78206-18336df8520-85eb-4286-81c3-db26a26ed7af12023-08-08

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 8 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
Bestmade Natural Products BM213GRAPHITES, RHUS TOX, NATRUM SULPH, CARBO VEG, NAT PHOSBestmade Natural Products2f6d9587-7185-7fef-e063-6394a90aa6fd2025-03-03WarningsExact identifier
unii: 70WT22SF4B
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Natrum Phosphoricum 6XNATRUM PHOSPHORICUMSEVENE USAff0d77ad-3e04-25ea-e053-6294a90a0def2025-02-11WarningsExact identifier
unii: 70WT22SF4B
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 70WT22SF4B
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: 70WT22SF4B
Jacksons Cell Salts NAT PHOS 6X 10NATRUM PHOSPHORICUMZettl Health Inc.2d5cf8f3-2bdb-b489-e063-6394a90abce32025-02-04Exact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: 70WT22SF4B
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
unii: B22547B95K
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-85HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.83f43207-76bb-4fc0-b3fc-45614da43e232025-01-13WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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