ATryn

Product NDC
42976-125
11-digit product format
429760125
Labeler code
42976
Product ID
42976-125_634fb454-4f7f-4b30-9f89-fd3a122cf074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Antithrombin Recombinant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
rEVO Biologics, Inc.
Application
BLA125284
Marketing category
BLA
Marketing start
2009-05-06
Marketing end
0000-00-00
Substance
ANTITHROMBIN ALFA
Active strength
525 [iU]/mL
Pharmacologic classes
Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA],Recombinant Antithrombin [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42976-125-012021-09-10C16284748780-19d75b9d0-2d10-f424-e053-dadaa90a57ceecc5f10c-e89e-4757-a56a-9cfa6fd383f7
42976-125-012020-01-31C16284748780-19d75b9d0-2d10-f424-e053-dadaa90a57ceecc5f10c-e89e-4757-a56a-9cfa6fd383f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42976-125-01429760125011 VIAL in 1 CARTON (42976-125-01) > 3 mL in 1 VIAL1 vial2014-06-090000-00-00NoNoCurrent