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 84612-479
Product ID 84612-479_ebaefae6-3b2d-4d1f-8f59-ecc6f0061607
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 84612479
Hyphenated Format 84612-479

Supplemental Identifiers

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 (84612-479-01) / .4 mL in 1 SYRINGE
  • 2 SYRINGE in 1 CARTON (84612-479-02) / .4 mL in 1 SYRINGE
source: ndc

Packages (2)

84612-479-01 1 SYRINGE in 1 CARTON (84612-479-01) / .4 mL in 1 SYRINGE 84612-479-02 2 SYRINGE in 1 CARTON (84612-479-02) / .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": "ebaefae6-3b2d-4d1f-8f59-ecc6f0061607", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "upc": ["0384612399012", "0384612479028"], "unii": ["FYS6T7F842"], "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 (84612-479-01)  / .4 mL in 1 SYRINGE", "package_ndc": "84612-479-01", "marketing_start_date": "20250101"}, {"sample": false, "description": "2 SYRINGE in 1 CARTON (84612-479-02)  / .4 mL in 1 SYRINGE", "package_ndc": "84612-479-02", "marketing_start_date": "20250101"}], "brand_name": "AMJEVITA", "product_id": "84612-479_ebaefae6-3b2d-4d1f-8f59-ecc6f0061607", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "84612-479", "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"}