FDA.reportPublic FDA data

Coagadex

Product NDC
64208-7752
Requested package NDC
64208-7752-1
11-digit product format
642087752
Labeler code
64208
Product ID
64208-7752_da6c9eef-d88e-4d24-96f4-87081ccf7dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Coagulation Factor X Human
Dosage form
KIT
Labeler
Bio Products Laboratory Ltd
Application
BLA125506
Marketing category
BLA
Marketing start
2015-10-21
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64208-775264208-7752-1IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64208-775264208-7752-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Coagadex
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1719235Internal RxNorm lookup
1719240Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad20e6ff-98bc-47e6-aa00-7fb441edd2b0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-03-30These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]
2021-03-30These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]
2021-03-30These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]
2020-01-31These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]
2020-01-31These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]
2020-01-31These highlights do not include all the information needed to use COAGADEX ® safely and effectively. See full prescribing information for COAGADEX ® . COAGADEX ® (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64208-7752-1Coagadex1 in 1 CARTONKIT115
64208-7754-1Coagadex10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL100 [iU] in 1mL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64208-7752-1EA - Each64208-77527456f9fe-df8e-4857-93b4-abe51ff9397212015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Coagulation Factor X HumanACTIVE INGREDIENT0P94UQE6SYCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3
Coagulation Factor X HumanACTIVE MOIETY0P94UQE6SYCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3
WaterINACTIVE INGREDIENT059QF0KO0RCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64208-7752COAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]12Current NDC, Legacy NDC, 2 package rows20241101_ad20e6ff-98bc-47e6-aa00-7fb441edd2b0.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CoagadexCOAGULATION FACTOR X HUMANBio Products Laboratory Ltdad20e6ff-98bc-47e6-aa00-7fb441edd2b02026-04-13Warnings, Adverse reactionsExact identifier
application number: BLA125506
ndc (package): 64208-7752-1
ndc (product): 64208-7752
ndc11 (package): 64208775201

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125506CoagadexCoagulation Factor X (Human)351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719240Coagadex 1 UNT InjectionPSNad20e6ff-98bc-47e6-aa00-7fb441edd2b015
1719235coagulation factor X, human 1 UNT InjectionPSNad20e6ff-98bc-47e6-aa00-7fb441edd2b015
1719240coagulation factor X, human 1 UNT Injection [Coagadex]SBDad20e6ff-98bc-47e6-aa00-7fb441edd2b015
1719235coagulation factor X, human 1 UNT InjectionSCDad20e6ff-98bc-47e6-aa00-7fb441edd2b015
1719240Coagadex 1 UNT InjectionSYad20e6ff-98bc-47e6-aa00-7fb441edd2b015
1719235coagulation factor X human 1 UNT InjectionSYad20e6ff-98bc-47e6-aa00-7fb441edd2b015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64208-7752-1642087752011 KIT in 1 CARTON (64208-7752-1) * 10 mL in 1 VIAL, GLASS (64208-7754-1) * 2.5 mL in 1 VIAL, GLASS (64208-7755-1) 1 kit2015-10-210000-00-00NoNoCurrent