amphadase

Generic: hyaluronidase

Labeler: amphastar pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name amphadase
Generic Name hyaluronidase
Labeler amphastar pharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase 150 [USP'U]/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-9090
Product ID 0548-9090_188cabde-5b1f-4083-8b6c-5dcb85f728d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021665
Listing Expiration 2026-12-31
Marketing Start 2004-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05489090
Hyphenated Format 0548-9090

Supplemental Identifiers

RxCUI
238271 542925
UNII
8KOG53Z5EM
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 amphadase (source: ndc)
Generic Name hyaluronidase (source: ndc)
Application Number BLA021665 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 150 [USP'U]/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0548-9090-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

hyaluronidase (150 [USP'U]/mL)

Linked Drug Pages (1)

AMPHADASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "188cabde-5b1f-4083-8b6c-5dcb85f728d2", "openfda": {"nui": ["N0000175531", "M0009499"], "unii": ["8KOG53Z5EM"], "rxcui": ["238271", "542925"], "spl_set_id": ["8396ea96-7cb5-4e26-87a4-90bca9c3c6dd"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0548-9090-10", "marketing_start_date": "20041026"}], "brand_name": "AMPHADASE", "product_id": "0548-9090_188cabde-5b1f-4083-8b6c-5dcb85f728d2", "dosage_form": "INJECTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "0548-9090", "generic_name": "hyaluronidase", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMPHADASE", "active_ingredients": [{"name": "HYALURONIDASE", "strength": "150 [USP'U]/mL"}], "application_number": "BLA021665", "marketing_category": "BLA", "marketing_start_date": "20041026", "listing_expiration_date": "20261231"}