FDA.reportPublic FDA data

THROMBIN-JMI

Product NDC
60793-705
11-digit product format
607930705
Labeler code
60793
Product ID
60793-705_1b500208-5932-4f29-810d-4a69d890f3ff
Type
PLASMA DERIVATIVE
Nonproprietary name
thrombin, topical (bovine)
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA102865
Marketing category
BLA
Marketing start
1995-02-24
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60793-315-01THROMBIN-JMI5 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION5 mL5000 [iU] in 5mL41
60793-705-05THROMBIN-JMI1 in 1 CARTONKIT141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-705-05EA - Each60793-7055af1690c-dc68-4001-8a74-66d4d767d4c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THROMBINACTIVE INGREDIENT25ADE2236LTHROMBIN-JMI (THROMBIN, TOPICAL (BOVINE)) KIT [PFIZER LABORATORIES DIV PFIZER INC]13
THROMBINACTIVE MOIETY25ADE2236LTHROMBIN-JMI (THROMBIN, TOPICAL (BOVINE)) KIT [PFIZER LABORATORIES DIV PFIZER INC]13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
102865Thrombin-Jmi, ThrombocollThrombin, Topical (Bovine)351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757667Thrombin-JMI 2000 UNT in 1 ML Topical SolutionPSNba8fcebf-a924-488f-983d-088892761f0e41
1243771Thrombin-JMI 2000 UNT in 1 ML Topical SprayPSNba8fcebf-a924-488f-983d-088892761f0e41
1243786Thrombin-JMI 5000 UNT in 5 mL Epistaxis Nasal SprayPSNba8fcebf-a924-488f-983d-088892761f0e41
757665thrombin, bovine 2000 UNT in 1 mL Topical SolutionPSNba8fcebf-a924-488f-983d-088892761f0e41
1243769thrombin, bovine 2000 UNT in 1 mL Topical SprayPSNba8fcebf-a924-488f-983d-088892761f0e41
757669thrombin, bovine 5000 UNT in 5 mL Epistaxis Nasal SprayPSNba8fcebf-a924-488f-983d-088892761f0e41
1243786thrombin, bovine 2000 UNT/ML Nasal Spray [Thrombin-JMI]SBDba8fcebf-a924-488f-983d-088892761f0e41
757667thrombin, bovine 2000 UNT/ML Topical Solution [Thrombin-JMI]SBDba8fcebf-a924-488f-983d-088892761f0e41
1243771thrombin, bovine 2000 UNT/ML Topical Spray [Thrombin-JMI]SBDba8fcebf-a924-488f-983d-088892761f0e41
757669thrombin, bovine 2000 UNT/ML Nasal SpraySCDba8fcebf-a924-488f-983d-088892761f0e41
757665thrombin, bovine 2000 UNT/ML Topical SolutionSCDba8fcebf-a924-488f-983d-088892761f0e41
1243769thrombin, bovine 2000 UNT/ML Topical SpraySCDba8fcebf-a924-488f-983d-088892761f0e41
757667Thrombin-JMI 2000 UNT per 1 ML Topical SolutionSYba8fcebf-a924-488f-983d-088892761f0e41
1243771Thrombin-JMI 2000 UNT per 1 ML Topical SpraySYba8fcebf-a924-488f-983d-088892761f0e41
1243786Thrombin-JMI 2000 UNT/ML Nasal SpraySYba8fcebf-a924-488f-983d-088892761f0e41
757667Thrombin-JMI 2000 UNT/ML Topical SolutionSYba8fcebf-a924-488f-983d-088892761f0e41
1243771Thrombin-JMI 2000 UNT/ML Topical SpraySYba8fcebf-a924-488f-983d-088892761f0e41
1243786Thrombin-JMI 5,000 UNT per 5 ML Epistaxis KitSYba8fcebf-a924-488f-983d-088892761f0e41
757665thrombin, bovine 2000 UNT per 1 ML Topical SolutionSYba8fcebf-a924-488f-983d-088892761f0e41
1243769thrombin, bovine 2000 UNT per 1 ML Topical SpraySYba8fcebf-a924-488f-983d-088892761f0e41
757669thrombin, bovine 5000 UNT per 5 ML Epistaxis KitSYba8fcebf-a924-488f-983d-088892761f0e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-315-01607930315015 mL in 1 VIAL, GLASS5 mlHistorical
60793-705-05607930705051 KIT in 1 CARTON (60793-705-05) * 5 mL in 1 VIAL, GLASS (60793-315-01) * 5 mL in 1 VIAL, GLASS (60793-218-09) 1 kit1995-02-240000-00-00NoNoCurrent