Adalimumab-bwwd

Product NDC
83457-187
11-digit product format
834570187
Labeler code
83457
Product ID
83457-187_62d117b6-ce78-4e27-9599-fcde5bc476db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-bwwd
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Cordavis Limited
Application
BLA761059
Marketing category
BLA
Marketing start
2025-12-12
Substance
ADALIMUMAB
Active strength
40 mg/.4mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adalimumab-bwwd
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2640425, 2640430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83457-187-01Adalimumab-bwwd2 in 1 CARTONSOLUTION22
83457-187-99Adalimumab-bwwd0.4 mL in 1 SYRINGESOLUTION0.42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-187-01ML - Milliliter83457-18726e08cc9-13c7-4f83-8399-d4a978f0b5fa12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640430adalimumab-bwwd 40 MG in 0.4 ML Auto-InjectorPSNc24655e5-796e-4127-b716-92f08d649c832
2640425adalimumab-bwwd 40 MG in 0.4 ML Prefilled SyringePSNc24655e5-796e-4127-b716-92f08d649c832
26404300.4 ML adalimumab-bwwd 100 MG/ML Auto-InjectorSCDc24655e5-796e-4127-b716-92f08d649c832
26404250.4 ML adalimumab-bwwd 100 MG/ML Prefilled SyringeSCDc24655e5-796e-4127-b716-92f08d649c832
2640430adalimumab-bwwd 40 MG per 0.4 ML Auto-InjectorSYc24655e5-796e-4127-b716-92f08d649c832
2640425adalimumab-bwwd 40 MG per 0.4 ML Prefilled SyringeSYc24655e5-796e-4127-b716-92f08d649c832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83457-187-01834570187012 SYRINGE in 1 CARTON (83457-187-01) / .4 mL in 1 SYRINGE (83457-187-99) 2 syringe2025-12-12NoNoHistorical
83457-187-99834570187990.4 mL in 1 SYRINGE0.4 mlHistorical