hyrimoz

Generic: adalimumab-adaz

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

Drug Facts

Product Profile

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

adalimumab 80 mg/.8mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-454
Product ID 61314-454_af358c91-4472-4fb1-87ba-001d67f2b4f8
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 61314454
Hyphenated Format 61314-454

Supplemental Identifiers

RxCUI
2641644 2641650 2641653 2641654 2641655 2641658 2641660 2641661 2641662 2641663 2641664 2641665 2641666 2641667 2641668 2641669 2641670 2641671 2641672 2641673
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
  • 80 mg/.8mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (61314-454-20) / .8 mL in 1 SYRINGE
  • 3 SYRINGE in 1 CARTON (61314-454-36) / .8 mL in 1 SYRINGE
  • 3 SYRINGE, GLASS in 1 CARTON (61314-454-68) / .8 mL in 1 SYRINGE, GLASS
source: ndc

Packages (3)

61314-454-20 2 SYRINGE in 1 CARTON (61314-454-20) / .8 mL in 1 SYRINGE 61314-454-36 3 SYRINGE in 1 CARTON (61314-454-36) / .8 mL in 1 SYRINGE 61314-454-68 3 SYRINGE, GLASS in 1 CARTON (61314-454-68) / .8 mL in 1 SYRINGE, GLASS

Ingredients (1)

adalimumab (80 mg/.8mL)

Linked Drug Pages (1)

HYRIMOZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "af358c91-4472-4fb1-87ba-001d67f2b4f8", "openfda": {"nui": ["N0000175610", "N0000175451", "M0001357"], "unii": ["FYS6T7F842"], "rxcui": ["2641644", "2641650", "2641653", "2641654", "2641655", "2641658", "2641660", "2641661", "2641662", "2641663", "2641664", "2641665", "2641666", "2641667", "2641668", "2641669", "2641670", "2641671", "2641672", "2641673"], "spl_set_id": ["1ac7d061-3380-468c-b077-c05f8dfbc829"], "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 (61314-454-20)  / .8 mL in 1 SYRINGE", "package_ndc": "61314-454-20", "marketing_start_date": "20230701"}, {"sample": false, "description": "3 SYRINGE in 1 CARTON (61314-454-36)  / .8 mL in 1 SYRINGE", "package_ndc": "61314-454-36", "marketing_start_date": "20230701"}, {"sample": false, "description": "3 SYRINGE, GLASS in 1 CARTON (61314-454-68)  / .8 mL in 1 SYRINGE, GLASS", "package_ndc": "61314-454-68", "marketing_start_date": "20230701"}], "brand_name": "HYRIMOZ", "product_id": "61314-454_af358c91-4472-4fb1-87ba-001d67f2b4f8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "61314-454", "generic_name": "adalimumab-adaz", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYRIMOZ", "active_ingredients": [{"name": "ADALIMUMAB", "strength": "80 mg/.8mL"}], "application_number": "BLA761071", "marketing_category": "BLA", "marketing_start_date": "20230701", "listing_expiration_date": "20271231"}