amjevita

Generic: adalimumab-atto

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

Drug Facts

Product Profile

Brand Name amjevita
Generic Name adalimumab-atto
Labeler nuvaila limited
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

adalimumab 40 mg/.4mL

Manufacturer
Nuvaila Limited

Identifiers & Regulatory

Product NDC 84612-482
Product ID 84612-482_494c8f53-855d-f506-e063-6294a90ac829
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761024
Listing Expiration 2027-12-31
Marketing Start 2025-01-01

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 84612482
Hyphenated Format 84612-482

Supplemental Identifiers

RxCUI
2663901 2663904 2663906 2663907 2663908 2663910 2663914 2663915
UPC
0384612399012 0384612479028
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 amjevita (source: ndc)
Generic Name adalimumab-atto (source: ndc)
Application Number BLA761024 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/.4mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (84612-482-01) / .4 mL in 1 SYRINGE
  • 2 SYRINGE in 1 CARTON (84612-482-02) / .4 mL in 1 SYRINGE
source: ndc

Packages (2)

84612-482-01 1 SYRINGE in 1 CARTON (84612-482-01) / .4 mL in 1 SYRINGE 84612-482-02 2 SYRINGE in 1 CARTON (84612-482-02) / .4 mL in 1 SYRINGE

Ingredients (1)

adalimumab (40 mg/.4mL)

Linked Drug Pages (1)

AMJEVITA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "494c8f53-855d-f506-e063-6294a90ac829", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "upc": ["0384612399012", "0384612479028"], "unii": ["FYS6T7F842"], "rxcui": ["2663901", "2663904", "2663906", "2663907", "2663908", "2663910", "2663914", "2663915"], "spl_set_id": ["d7862491-2634-4402-b001-dcc1abf8dd58"], "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": ["Nuvaila Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (84612-482-01)  / .4 mL in 1 SYRINGE", "package_ndc": "84612-482-01", "marketing_start_date": "20250101"}, {"sample": false, "description": "2 SYRINGE in 1 CARTON (84612-482-02)  / .4 mL in 1 SYRINGE", "package_ndc": "84612-482-02", "marketing_start_date": "20250101"}], "brand_name": "AMJEVITA", "product_id": "84612-482_494c8f53-855d-f506-e063-6294a90ac829", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "84612-482", "generic_name": "adalimumab-atto", "labeler_name": "Nuvaila Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMJEVITA", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "40 mg/.4mL"}], "application_number": "BLA761024", "marketing_category": "BLA", "marketing_start_date": "20250101", "listing_expiration_date": "20271231"}