FDA.reportPublic FDA data

Revcovi

Product NDC
10122-502
11-digit product format
101220502
Labeler code
10122
Product ID
10122-502_964401e1-52e5-4c34-b5b5-d028ce092dd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elapegademase-lvlr
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Chiesi USA, Inc.
Application
BLA761092
Marketing category
BLA
Marketing start
2018-10-05
Substance
ELAPEGADEMASE
Active strength
1.6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Revcovi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELAPEGADEMASE1.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9R3D3Y0UHSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2059223Internal RxNorm lookup
2059228Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c073f84-cdd0-40e4-b3a9-172687267f28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
8a4c9dd7-f6a5-461b-96dc-ddb1ef87f802Product name120190117
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-502-01Revcovi1.5 mL in 1 VIALINJECTION1.55
10122-502-01Revcovi1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-502-01ML - Milliliter10122-50221f32e97-9a65-4e57-8858-29b1ed7f5d6512022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-502REVCOVI (ELAPEGADEMASE-LVLR) INJECTION [CHIESI USA, INC.]5Current NDC, Legacy NDC, 2 package rows20220902_8c073f84-cdd0-40e4-b3a9-172687267f28.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevcoviELAPEGADEMASE-LVLRChiesi USA, Inc.8c073f84-cdd0-40e4-b3a9-172687267f282026-05-31Warnings, Adverse reactionsExact identifier
application number: BLA761092
ndc (product): 10122-502

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761092Revcovielapegademase-lvlr351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059223elapegademase-lvlr 2.4 MG in 1.5 ML InjectionPSN8c073f84-cdd0-40e4-b3a9-172687267f285
2059228Recovi 2.4 MG in 1.5 ML InjectionPSN8c073f84-cdd0-40e4-b3a9-172687267f285
20592281.5 ML elapegademase-lvlr 1.6 MG/ML Injection [Revcovi]SBD8c073f84-cdd0-40e4-b3a9-172687267f285
20592231.5 ML elapegademase-lvlr 1.6 MG/ML InjectionSCD8c073f84-cdd0-40e4-b3a9-172687267f285
20592281.5 ML Revcovi 1.6 MG/ML InjectionSY8c073f84-cdd0-40e4-b3a9-172687267f285
2059223elapegademase-lvlr 2.4 MG per 1.5 ML InjectionSY8c073f84-cdd0-40e4-b3a9-172687267f285
2059228Recovi 2.4 MG per 1.5 ML InjectionSY8c073f84-cdd0-40e4-b3a9-172687267f285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10122-502-01101220502011 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIAL1 vial2018-10-050000-00-00NoNoCurrent