amjevita

Generic: adalimumab-atto

Labeler: amgen usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name amjevita
Generic Name adalimumab-atto
Labeler amgen usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

adalimumab 40 mg/.8mL

Manufacturer
Amgen USA Inc.

Identifiers & Regulatory

Product NDC 72511-400
Product ID 72511-400_51727964-061d-4c73-a22e-0c2e1cd571b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761024
Listing Expiration 2026-12-31
Marketing Start 2023-01-31

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 72511400
Hyphenated Format 72511-400

Supplemental Identifiers

RxCUI
2627719 2627722 2663901 2663904 2663906 2663907 2663908 2663910 2663914 2663915
UPC
0000000000000 0372511481020 0372511482027 0071100008975 0372511400014
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/.8mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (72511-400-01) / .8 mL in 1 SYRINGE
  • 2 SYRINGE in 1 CARTON (72511-400-02) / .8 mL in 1 SYRINGE
source: ndc

Packages (2)

72511-400-01 1 SYRINGE in 1 CARTON (72511-400-01) / .8 mL in 1 SYRINGE 72511-400-02 2 SYRINGE in 1 CARTON (72511-400-02) / .8 mL in 1 SYRINGE

Ingredients (1)

adalimumab (40 mg/.8mL)

Linked Drug Pages (1)

AMJEVITA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "51727964-061d-4c73-a22e-0c2e1cd571b0", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "upc": ["0000000000000", "0372511481020", "0372511482027", "0071100008975", "0372511400014"], "unii": ["FYS6T7F842"], "rxcui": ["2627719", "2627722", "2663901", "2663904", "2663906", "2663907", "2663908", "2663910", "2663914", "2663915"], "spl_set_id": ["b7178e36-6787-45ab-8fee-be59bc6a4aa4"], "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": ["Amgen USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (72511-400-01)  / .8 mL in 1 SYRINGE", "package_ndc": "72511-400-01", "marketing_start_date": "20230131"}, {"sample": false, "description": "2 SYRINGE in 1 CARTON (72511-400-02)  / .8 mL in 1 SYRINGE", "package_ndc": "72511-400-02", "marketing_start_date": "20230131"}], "brand_name": "AMJEVITA", "product_id": "72511-400_51727964-061d-4c73-a22e-0c2e1cd571b0", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "72511-400", "generic_name": "adalimumab-atto", "labeler_name": "Amgen USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMJEVITA", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "40 mg/.8mL"}], "application_number": "BLA761024", "marketing_category": "BLA", "marketing_start_date": "20230131", "listing_expiration_date": "20261231"}