hadlima

Generic: adalimumab-bwwd

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name hadlima
Generic Name adalimumab-bwwd
Labeler organon llc
Dosage Form SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

adalimumab 40 mg/.8mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-183
Product ID 78206-183_80094579-29f3-49ee-b962-1e92ef8a4eb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761059
Listing Expiration 2027-12-31
Marketing Start 2023-07-01

Pharmacologic Class

Established (EPC)
tumor necrosis factor blocker [epc]
Mechanism of Action
tumor necrosis factor receptor blocking activity [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206183
Hyphenated Format 78206-183

Supplemental Identifiers

RxCUI
2640287 2640300 2640302 2640305 2640419 2640422 2640425 2640428 2640430 2640432
UNII
FYS6T7F842
NUI
N0000175610 N0000175451 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hadlima (source: ndc)
Generic Name adalimumab-bwwd (source: ndc)
Application Number BLA761059 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/.8mL
source: ndc
Packaging
  • 2 CARTON in 1 CARTON (78206-183-01) / 1 SYRINGE in 1 CARTON (78206-183-99) / .8 mL in 1 SYRINGE
source: ndc

Packages (1)

78206-183-01 2 CARTON in 1 CARTON (78206-183-01) / 1 SYRINGE in 1 CARTON (78206-183-99) / .8 mL in 1 SYRINGE

Ingredients (1)

adalimumab (40 mg/.8mL)

Linked Drug Pages (1)

Hadlima ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "80094579-29f3-49ee-b962-1e92ef8a4eb9", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "unii": ["FYS6T7F842"], "rxcui": ["2640287", "2640300", "2640302", "2640305", "2640419", "2640422", "2640425", "2640428", "2640430", "2640432"], "spl_set_id": ["4774a951-3ce8-43b6-80b1-e6b23752aae6"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 CARTON (78206-183-01)  / 1 SYRINGE in 1 CARTON (78206-183-99)  / .8 mL in 1 SYRINGE", "package_ndc": "78206-183-01", "marketing_start_date": "20230701"}], "brand_name": "Hadlima", "product_id": "78206-183_80094579-29f3-49ee-b962-1e92ef8a4eb9", "dosage_form": "SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "78206-183", "generic_name": "adalimumab-bwwd", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hadlima", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "40 mg/.8mL"}], "application_number": "BLA761059", "marketing_category": "BLA", "marketing_start_date": "20230701", "listing_expiration_date": "20271231"}