adalimumab

Generic: adalimumab-adaz

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name adalimumab
Generic Name adalimumab-adaz
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

adalimumab 40 mg/.4mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-327
Product ID 61314-327_ae54abc4-e9c5-4c5a-8fa7-968e5ad72050
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761071
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 61314327
Hyphenated Format 61314-327

Supplemental Identifiers

RxCUI
2641644 2641653 2641655 2641660 2641662
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 adalimumab (source: ndc)
Generic Name adalimumab-adaz (source: ndc)
Application Number BLA761071 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/.4mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (61314-327-20) / .4 mL in 1 SYRINGE
  • 2 SYRINGE, GLASS in 1 CARTON (61314-327-64) / .4 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

61314-327-20 2 SYRINGE in 1 CARTON (61314-327-20) / .4 mL in 1 SYRINGE 61314-327-64 2 SYRINGE, GLASS in 1 CARTON (61314-327-64) / .4 mL in 1 SYRINGE, GLASS

Ingredients (1)

adalimumab (40 mg/.4mL)

Linked Drug Pages (1)

Adalimumab ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ae54abc4-e9c5-4c5a-8fa7-968e5ad72050", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "unii": ["FYS6T7F842"], "rxcui": ["2641644", "2641653", "2641655", "2641660", "2641662"], "spl_set_id": ["3468792f-63ef-4916-8ed1-8214f327d9dd"], "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": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (61314-327-20)  / .4 mL in 1 SYRINGE", "package_ndc": "61314-327-20", "marketing_start_date": "20230701"}, {"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (61314-327-64)  / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "61314-327-64", "marketing_start_date": "20230701"}], "brand_name": "Adalimumab", "product_id": "61314-327_ae54abc4-e9c5-4c5a-8fa7-968e5ad72050", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "61314-327", "generic_name": "adalimumab-adaz", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adalimumab", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "40 mg/.4mL"}], "application_number": "BLA761071", "marketing_category": "BLA", "marketing_start_date": "20230701", "listing_expiration_date": "20271231"}