RECOTHROM

Product NDC: 65293-007
11-digit product format: 652930007
Labeler code: 65293
Product ID: 65293-007_b62b217c-4f03-44cf-b038-84bbc84c9179
Type: PLASMA DERIVATIVE
Nonproprietary name: Thrombin topical Recombinant
Dosage form: KIT
Labeler: The Medicines Company
Application: BLA125248
Marketing category: BLA
Marketing start: 2008-06-09
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65293-007		I	Inactivated by FDA	2026-09-14
excluded package	package	65293-007	65293-007-41	I	Inactivated by FDA	2026-09-14
excluded package	package	65293-007	65293-007-50	I	Inactivated by FDA	2026-09-14

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65293-007-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65293-007-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65293-007-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65293-007-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65293-007-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65293-007-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65293-007-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65293-007-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65293-007-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65293-007-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65293-007-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65293-007-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65293-007-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65293-007-41	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65293-007-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65293-007-41	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65293-007-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65293-007-41	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65293-007-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65293-007-41	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65293-007-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65293-007-41	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65293-007-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65293-007-41	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65293-007-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65293-007-41	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65293-007-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65293-007-41	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65293-007-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65293-007-41	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65293-007-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65293-007-41	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65293-007-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65293-007-41	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65293-007-50	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65293-007-41	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65293-007-50	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65293-007-41	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65293-007-50	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65293-007-41	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65293-007-41	2019-11-27	C162847	48780-1	9855e2a2-441f-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM, Thrombin topical (Recombinant) Lyophilized Powder for Solution - For Topical Use Only Initial U.S. Approval: 2008
65293-007-50	2019-11-27	C162847	48780-1	9855e2a2-441f-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM, Thrombin topical (Recombinant) Lyophilized Powder for Solution - For Topical Use Only Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65293-007-41	RECOTHROM	1 in 1 KIT	KIT	1		8
65293-007-50	RECOTHROM	1 in 1 KIT	KIT	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65293-007-41	EA - Each	65293-007	0922fdfe-9e72-4648-ad19-6b6b6cd7db70	1	2015-02-02
65293-007-50	EA - Each	65293-007	9034dff5-cff5-4c9c-bab0-ea45dedf38db	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THROMBIN ALFA	ACTIVE INGREDIENT	SCK81AMR7R	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
THROMBIN ALFA	ACTIVE MOIETY	SCK81AMR7R	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65293-007	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]	8	Legacy NDC, 2 package rows	20140917_bcf44467-b1eb-479b-8866-a8ac2c780c22.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RECOTHROM	THROMBIN TOPICAL RECOMBINANT	Baxter Healthcare Corporation	54885644-e51e-4263-aadb-366abaeb56a3	2025-06-09	Warnings, Adverse reactions	Exact identifier application number: BLA125248

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125248	Recothrom	Thrombin topical (Recombinant)	351(a)	Rx	2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1367420	Recothrom 1000 UNT in 1 ML Topical Solution	PSN	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367418	thrombin alfa 1000 UNT in 1 ML Topical Solution	PSN	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367420	thrombin alfa 1000 UNT/ML Topical Solution [Recothrom]	SBD	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367418	thrombin alfa 1000 UNT/ML Topical Solution	SCD	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367418	alfa-thrombin 1000 UNT/ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367420	Recothrom 1000 UNT per 1 ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367420	Recothrom 1000 UNT/ML (as alfa-thrombin) Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367420	Recothrom 20,000 UNT per 20 ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367420	Recothrom 5,000 UNT per 5 ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367418	thrombin alfa 1000 UNT per 1 ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8
1367418	thrombin alfa 20,000 UNT per 20 ML Topical Solution	SY	bcf44467-b1eb-479b-8866-a8ac2c780c22	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65293-007-41	65293000741	1 in 1 KIT	Historical
65293-007-50	65293000750	1 in 1 KIT	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RECOTHROM	The Medicines Company \| AbbVie BioResearch Center \| Anderson Brecon Inc \| Cook Pharmica LLC \| Patheon Italia S.p.A \| Sharp Corporation \| Zymogenetics	2014-09-10	PLASMA DERIVATIVE	8