Coagadex

Product NDC
64208-7753
11-digit product format
642087753
Labeler code
64208
Product ID
64208-7753_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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1719235, 1719240

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64208-7753-12021-03-30C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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]
64208-7753-12021-03-30C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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]
64208-7753-12021-03-30C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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]
64208-7753-12020-01-31C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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]
64208-7753-12020-01-31C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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]
64208-7753-12020-01-31C16284748780-19d75b9d1-1bc3-f424-e053-dadaa90a57ceThese 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
64208-7753-1Coagadex1 in 1 CARTONKIT115
64208-7756-1Coagadex10 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
64208-7753-1EA - Each64208-7753707e4fbd-6e27-4f39-bf8f-ae4f61d0e60512015-12-02

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
64208-7753COAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]12Current NDC, Legacy NDC, 2 package rows20241101_ad20e6ff-98bc-47e6-aa00-7fb441edd2b0.zip

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
64208-7753-1642087753011 KIT in 1 CARTON (64208-7753-1) * 10 mL in 1 VIAL, GLASS (64208-7756-1) * 5 mL in 1 VIAL, GLASS (64208-7755-2) 1 kit2015-10-210000-00-00NoNoCurrent
64208-7756-16420877560110 mL in 1 VIAL, GLASS10 mlHistorical