hylenex recombinant

Generic: hyaluronidase

Labeler: antares pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name hylenex recombinant
Generic Name hyaluronidase
Labeler antares pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase (human recombinant) 150 [USP'U]/mL

Manufacturer
Antares Pharma, Inc.

Identifiers & Regulatory

Product NDC 18657-117
Product ID 18657-117_37c02d08-e964-4065-ba96-69fe8eed5c2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021859
Listing Expiration 2026-12-31
Marketing Start 2005-12-02

Pharmacologic Class

Established (EPC)
endoglycosidase [epc]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 18657117
Hyphenated Format 18657-117

Supplemental Identifiers

RxCUI
630936 630939
UNII
743QUY4VD8
NUI
N0000175531 M0009499

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 hylenex recombinant (source: ndc)
Generic Name hyaluronidase (source: ndc)
Application Number BLA021859 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 150 [USP'U]/mL
source: ndc
Packaging
  • 4 BOX in 1 CARTON (18657-117-04) / 1 VIAL in 1 BOX (18657-117-02) / 1 mL in 1 VIAL (18657-117-01)
source: ndc

Packages (1)

18657-117-04 4 BOX in 1 CARTON (18657-117-04) / 1 VIAL in 1 BOX (18657-117-02) / 1 mL in 1 VIAL (18657-117-01)

Ingredients (1)

hyaluronidase (human recombinant) (150 [USP'U]/mL)

Linked Drug Pages (1)

HYLENEX Recombinant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "37c02d08-e964-4065-ba96-69fe8eed5c2e", "openfda": {"nui": ["N0000175531", "M0009499"], "unii": ["743QUY4VD8"], "rxcui": ["630936", "630939"], "spl_set_id": ["3023cc56-ed4b-4e87-b3a1-81b20943f658"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]"], "manufacturer_name": ["Antares Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOX in 1 CARTON (18657-117-04)  / 1 VIAL in 1 BOX (18657-117-02)  / 1 mL in 1 VIAL (18657-117-01)", "package_ndc": "18657-117-04", "marketing_start_date": "20051202"}], "brand_name": "HYLENEX Recombinant", "product_id": "18657-117_37c02d08-e964-4065-ba96-69fe8eed5c2e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "18657-117", "generic_name": "Hyaluronidase", "labeler_name": "Antares Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYLENEX Recombinant", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "150 [USP'U]/mL"}], "application_number": "BLA021859", "marketing_category": "BLA", "marketing_start_date": "20051202", "listing_expiration_date": "20261231"}