THROMBATE III

Product NDC
13533-602
11-digit product format
135330602
Labeler code
13533
Product ID
13533-602_1f6e9772-889a-49b7-9c8a-7a29ed4b68fa
Type
PLASMA DERIVATIVE
Nonproprietary name
ANTITHROMBIN III (HUMAN)
Dosage form
KIT
Labeler
GRIFOLS USA, LLC
Application
BLA103196
Marketing category
BLA
Marketing start
1991-12-30
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THROMBATE III
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-602-50THROMBATE III1 in 1 CARTONKIT131
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-602-50EA - Each13533-6027f8c0b1a-f703-4b2a-82cb-586700bfd33f12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-602THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Current NDC, Legacy NDC, 2 package rows20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659988antithrombin III, human 1 UNT InjectionPSNb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991Thrombate III 1 UNT InjectionPSNb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991antithrombin III, human 1 UNT Injection [Thrombate III]SBDb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659988antithrombin III, human 1 UNT InjectionSCDb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991Thrombate III 1 UNT InjectionSYb2a9f856-3ef7-8da4-920c-f738e4f1f7d731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-602-50135330602501 KIT in 1 CARTON (13533-602-50) * 10 mL in 1 VIAL, GLASS (13533-605-21) * 10 mL in 1 VIAL, GLASS (13533-200-10) 1 kit1991-12-300000-00-00NoNoCurrent
13533-605-211353306052110 mL in 1 VIAL, GLASS10 mlHistorical