FDA.reportPublic FDA data

Retavase

Product NDC
10122-141
11-digit product format
101220141
Labeler code
10122
Product ID
10122-141_91c28643-e5a8-49d2-af90-17fefeb5b827
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
reteplase
Dosage form
KIT
Labeler
Chiesi USA, Inc.
Application
BLA103786
Marketing category
BLA
Marketing start
1996-10-30
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10122-141DDiscontinued by firm2026-07-31
excluded packagepackage10122-14110122-141-02DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-141-02EA - Each10122-1413b05a074-739d-4eff-a289-536581bf2d5a12018-12-13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103786Retavasereteplase351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10122-141-02101220141021 KIT in 1 BOX (10122-141-02) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 SYRINGE (10122-142-01) 1 kit1996-10-300000-00-00NoNoCurrent