revcovi

Generic: elapegademase-lvlr

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

Drug Facts

Product Profile

Brand Name revcovi
Generic Name elapegademase-lvlr
Labeler chiesi usa, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

elapegademase 1.6 mg/mL

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-502
Product ID 10122-502_964401e1-52e5-4c34-b5b5-d028ce092dd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761092
Listing Expiration 2026-12-31
Marketing Start 2018-10-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122502
Hyphenated Format 10122-502

Supplemental Identifiers

RxCUI
2059223 2059228
UNII
9R3D3Y0UHS

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 revcovi (source: ndc)
Generic Name elapegademase-lvlr (source: ndc)
Application Number BLA761092 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 1.6 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

10122-502-01 1 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIAL

Ingredients (1)

elapegademase (1.6 mg/mL)

Linked Drug Pages (1)

Revcovi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "964401e1-52e5-4c34-b5b5-d028ce092dd9", "openfda": {"unii": ["9R3D3Y0UHS"], "rxcui": ["2059223", "2059228"], "spl_set_id": ["8c073f84-cdd0-40e4-b3a9-172687267f28"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (10122-502-01)  / 1.5 mL in 1 VIAL", "package_ndc": "10122-502-01", "marketing_start_date": "20181005"}], "brand_name": "Revcovi", "product_id": "10122-502_964401e1-52e5-4c34-b5b5-d028ce092dd9", "dosage_form": "INJECTION", "product_ndc": "10122-502", "generic_name": "elapegademase-lvlr", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Revcovi", "active_ingredients": [{"name": "ELAPEGADEMASE", "strength": "1.6 mg/mL"}], "application_number": "BLA761092", "marketing_category": "BLA", "marketing_start_date": "20181005", "listing_expiration_date": "20261231"}