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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42976-125		D	Discontinued by firm		2026-10-05
excluded package	package	42976-125	42976-125-01	D	Discontinued by firm		2026-10-05

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42976-125-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42976-125-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42976-125-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42976-125-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42976-125-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42976-125-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42976-125-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42976-125-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42976-125-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42976-125-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42976-125-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42976-125-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42976-125-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42976-125-01	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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42976-125-01	2021-09-10	C162847	48780-1	9d75b9d0-2d10-f424-e053-dadaa90a57ce	These 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
42976-125-01	2020-01-31	C162847	48780-1	9d75b9d0-2d10-f424-e053-dadaa90a57ce	These 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
Ingredient	Type	UNII	DailyMed label	SPL version
ANTITHROMBIN ALFA	ACTIVE INGREDIENT	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 [REVO BIOLOIGICS, INC.]	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	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 [REVO BIOLOIGICS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ATRYN (ANTITHROMBIN RECOMBINANT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVO BIOLOIGICS, 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AWV6I5L6H2	ANTITHROMBIN ALFA	84720-88-7	ANTITHROMBIN ALFA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42976-125-01	42976012501	1 VIAL in 1 CARTON (42976-125-01) > 3 mL in 1 VIAL	1 vial	2014-06-09	0000-00-00	No	No	Current