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 2 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM213CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOXTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b10-a115-5b4f-e063-6394a90a52412026-06-14WarningsExact identifier
unii: 70WT22SF4B
BM BM38 DROPSBERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODATTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410af95-519a-f0d5-e063-6294a90ac0cf2026-06-12WarningsExact identifier
unii: 70WT22SF4B
GUNA-KIDNEYCHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO MAJOR - PORK KIDNEY - POTASSIUM NITRATE - PROTEUS VULGARIS - QUINHYDRONE - SARSAPARILLA - SOLIDAGO VIRGAUREA FLOWERING TOP - SUCCINIC ACID - SUS SCROFA URETER - SUS SCROFA URINARY BLADDER -Guna spa45c3c1af-e2b4-4239-98d9-f675c0e7d3222026-06-11WarningsExact identifier
unii: AB6MNQ6J6L
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
unii: AB6MNQ6J6L
BM BM38 DROPSBERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODATBM Private Limited53f8163d-28c3-b3b3-e063-6394a90a86da2026-06-11WarningsExact identifier
unii: 70WT22SF4B
Jacksons Cell Salts DIGESTIVE BALANCENAT MUR, NAT PHOS, NAT SULPHZettl Health Inc.54018d0e-372f-8afc-e063-6394a90aeb152026-06-11WarningsExact identifier
unii: 70WT22SF4B
Jacksons Cell Salts 5 IN 1 PHOSCALC PHOS, FERRUM PHOS , KALI PHOS, MAG PHOS, NAT PHOSZettl Health Inc.53e85f92-5863-82f1-e063-6394a90af52e2026-06-10WarningsExact identifier
unii: 70WT22SF4B
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 70WT22SF4B
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d5058d-861a-9e20-e063-6294a90a164c2026-06-09WarningsExact identifier
unii: 70WT22SF4B
BM Nat PhosNATRUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53bacdaf-d7c8-9ae9-e063-6294a90a898c2026-06-08WarningsExact identifier
unii: 70WT22SF4B
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: 70WT22SF4B
BM Nat Phos Icing SugarNATRUM PHOSPHORICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356e3a2-11f9-98e5-e063-6294a90a08eb2026-06-03WarningsExact identifier
unii: 70WT22SF4B
BM NAT PHOS POTENCYNAT PHOSBM Private Limited53239eb6-1403-619c-e063-6394a90a49582026-05-31WarningsExact identifier
unii: 70WT22SF4B
BM BM213CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOXBM Private Limited52cca143-b5cd-e1d9-e063-6394a90a5b152026-05-27WarningsExact identifier
unii: 70WT22SF4B
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: B22547B95K
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsc361dd60-c88d-4f3c-b98c-79687bbc34502026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059
rxcui: 2640430
rxcui: 2640432
unii: FYS6T7F842
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
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: 506T60A25R

Reported adverse events (FAERS/openFDA)#

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