Home NDC 42976-121-02 ATryn
Product NDC 42976-121
Requested package NDC 42976-121-02
11-digit product format 429760121
Labeler code 42976
Product ID 42976-121_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 1750 [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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANTITHROMBIN ALFA ACTIVE INGREDIENT AWV6I5L6H2 ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1 ANTITHROMBIN ALFA ACTIVE INGREDIENT AWV6I5L6H2 ATRYN (ANTITHROMBIN (RECOMBINANT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GTC BIOTHERAPEUTICS, INC.] 1 ANTITHROMBIN ALFA ACTIVE MOIETY AWV6I5L6H2 ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1 ANTITHROMBIN ALFA ACTIVE MOIETY AWV6I5L6H2 ATRYN (ANTITHROMBIN (RECOMBINANT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GTC BIOTHERAPEUTICS, INC.] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C ATRYN (ANTITHROMBIN (RECOMBINANT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GTC BIOTHERAPEUTICS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ATRYN (ANTITHROMBIN (RECOMBINANT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GTC BIOTHERAPEUTICS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ATRYN (ANTITHROMBIN (RECOMBINANT)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GTC BIOTHERAPEUTICS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, INC.] 1
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125284 Atryn Antithrombin (Recombinant) 351(a) Disc 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42976-121-02 42976012102 1 VIAL in 1 CARTON (42976-121-02) > 3 mL in 1 VIAL 1 vial 2009-05-06 0000-00-00 No No Current