hyrimoz

Generic: adalimumab-adaz

Labeler: cordavis limited
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name hyrimoz
Generic Name adalimumab-adaz
Labeler cordavis limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

adalimumab 20 mg/.2mL

Manufacturer
Cordavis Limited

Identifiers & Regulatory

Product NDC 83457-108
Product ID 83457-108_04bedd16-44e8-4761-bb65-d4678c4013af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761071
Listing Expiration 2027-12-31
Marketing Start 2023-12-15

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 83457108
Hyphenated Format 83457-108

Supplemental Identifiers

RxCUI
2641653 2641654 2641655 2641658 2641660 2641661 2641662 2641663 2641664 2641665 2641670 2641671 2665419 2665422 2665424 2665426
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 hyrimoz (source: ndc)
Generic Name adalimumab-adaz (source: ndc)
Application Number BLA761071 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/.2mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (83457-108-01) / .2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

83457-108-01 2 SYRINGE, GLASS in 1 CARTON (83457-108-01) / .2 mL in 1 SYRINGE, GLASS

Ingredients (1)

adalimumab (20 mg/.2mL)

Linked Drug Pages (1)

HYRIMOZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "04bedd16-44e8-4761-bb65-d4678c4013af", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "unii": ["FYS6T7F842"], "rxcui": ["2641653", "2641654", "2641655", "2641658", "2641660", "2641661", "2641662", "2641663", "2641664", "2641665", "2641670", "2641671", "2665419", "2665422", "2665424", "2665426"], "spl_set_id": ["3e303a4a-980b-4f2a-9d03-786928758637"], "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": ["Cordavis Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (83457-108-01)  / .2 mL in 1 SYRINGE, GLASS", "package_ndc": "83457-108-01", "marketing_start_date": "20231215"}], "brand_name": "HYRIMOZ", "product_id": "83457-108_04bedd16-44e8-4761-bb65-d4678c4013af", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "83457-108", "generic_name": "adalimumab-adaz", "labeler_name": "Cordavis Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYRIMOZ", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "20 mg/.2mL"}], "application_number": "BLA761071", "marketing_category": "BLA", "marketing_start_date": "20231215", "listing_expiration_date": "20271231"}