FDA.reportPublic FDA data

NDC 83457-186-99 - Adalimumab-bwwd

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
83457-186
Requested NDC
83457-186-99
Package NDCs from labels
83457-186-99, 83457-186-01
Manufacturer
Cordavis Limited | 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
Adalimumab-bwwd - Cordavis Limited | Samsung Bioepis Co., Ltd.Cordavis Limited | Samsung Bioepis Co., Ltd.2025-10-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83457-186-01Adalimumab-bwwd2 in 1 CARTONSOLUTION22
83457-186-99Adalimumab-bwwd0.4 mL in 1 SYRINGESOLUTION0.42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-186-01ML - Milliliter83457-1863c2d43a2-f5f5-488a-a861-62a809bdca7512026-01-08

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 5 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
LUMO Booz Hangover CompaniionCHININUM ARSENICOSUM, NATRUM PHOSPHORICUM, NUX VOOMICA, VESPA CRABROApplied Bioenergetics, LLC8e23e541-2c78-4ca0-a61a-ad110665c7f32025-11-10WarningsExact identifier
unii: 70WT22SF4B
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Miranda Castros Phosphorus 5 Cell Salts For Physical and Emotional Fatigue, Stress and TensionCALCAREA PHOS, FERRUM PHOS, KALI PHOS, MAGNESIUM PHOS, NATRUM PHOSMIRANDA CASTRO'S SHOP, LLC2670fdeb-0c80-9f23-e063-6394a90a8c6a2025-10-23WarningsExact identifier
unii: 70WT22SF4B
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
AdalimumabADALIMUMAB-ADAZSandoz Inc3468792f-63ef-4916-8ed1-8214f327d9dd2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
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
HYRIMOZADALIMUMAB-ADAZSandoz Inc1ac7d061-3380-468c-b077-c05f8dfbc8292025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Adalimumab-bwwdADALIMUMAB-BWWDCordavis Limitedc24655e5-796e-4127-b716-92f08d649c832025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059
ndc (package): 83457-186-99
ndc (package): 83457-186-01
ndc (package): 83457-187-99
ndc (package): 83457-187-01
ndc (product): 83457-186
ndc (product): 83457-187
ndc11 (package): 83457018699
rxcui: 2640425
rxcui: 2640430
spl id: e4f35584-c5c1-4878-a715-8e09c488d05e
spl set id: c24655e5-796e-4127-b716-92f08d649c83
unii: FYS6T7F842
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.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: AB6MNQ6J6L
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSCivica, Inc.8fd901e6-30cb-411a-b820-b9e79625ec7c2025-08-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

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