FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42976-125DDiscontinued by firm2026-07-31
excluded packagepackage42976-12542976-125-01DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42976-125-012021-09-10C16284748780-19d75b9d0-2d10-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AT RYN safely and effectively. See full prescribing information for AT RYN . AT RYN (a ntithrombin (Recombinant) ) Lyophilized powder for solution for intravenous injection Initial U.S. Approval: 2009
42976-125-012020-01-31C16284748780-19d75b9d0-2d10-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AT RYN safely and effectively. See full prescribing information for AT RYN . AT RYN (a ntithrombin (Recombinant) ) Lyophilized powder for solution for intravenous injection Initial U.S. Approval: 2009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTITHROMBIN ALFAACTIVE INGREDIENTAWV6I5L6H2ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1
ANTITHROMBIN ALFAACTIVE MOIETYAWV6I5L6H2ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.]1

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125284AtrynAntithrombin (Recombinant)351(a)Disc2026-06-01

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