FDA.reportPublic FDA data

Argatroban

Product NDC
55150-241
11-digit product format
551500241
Labeler code
55150
Product ID
55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
NDA209552
Marketing category
NDA
Marketing start
2018-11-27
Substance
ARGATROBAN
Active strength
50 mg/50mL
Pharmacologic classes
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGATROBAN50 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIY90U61Z3S
Rxcui1804735

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5caa2eb2-babc-614c-a218-ce66a08b6250Product name820240906
c0269bcb-0bb6-4819-abd5-83630c6c2987Product name120220118
7d4566f6-82cc-84f2-3f0f-543d96572eb5Product name420190228
ed3df91f-3251-4663-a74b-c2f6abe53c44Product name120170719
198a0c8c-4635-4e68-a2c4-b1dc22075421Product name120150402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-241-01Argatroban50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION503
55150-241-01Argatroban1 in 1 CARTONINJECTION, SOLUTION13
55150-241-10Argatroban10 in 1 CARTONINJECTION, SOLUTION103
55150-241-10Argatroban50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-241-01ML - Milliliter55150-2413ffb722e-9d73-4b17-8860-e904b5531f7a12019-03-12
55150-241-10ML - Milliliter55150-241e6fa1250-6136-4b8a-9b17-15a3a2d7fd8412019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-241ARGATROBAN INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 4 package rows20230804_d9b975bd-e3f4-466e-96ca-7bef7899506d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804735argatroban 50 MG in 50 ML InjectionPSNd9b975bd-e3f4-466e-96ca-7bef7899506d3
180473550 ML argatroban 1 MG/ML InjectionSCDd9b975bd-e3f4-466e-96ca-7bef7899506d3
1804735argatroban 50 MG per 50 ML InjectionSYd9b975bd-e3f4-466e-96ca-7bef7899506d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-241-01551500241011 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE2018-11-270000-00-00NoNoCurrent
55150-241-105515002411010 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE2018-11-270000-00-00NoNoCurrent