FDA.reportPublic FDA data

Argatroban

Product NDC
68083-141
11-digit product format
680830141
Labeler code
68083
Product ID
68083-141_c07a92fe-93d4-456d-8df2-ce14959116b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA205570
Marketing category
ANDA
Marketing start
2017-05-26
Substance
ARGATROBAN
Active strength
125 mg/125mL
Pharmacologic classes
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGATROBAN125 mg/125mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIY90U61Z3S
Rxcui1804737

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
68083-141-01Argatroban125 mL in 1 VIALSOLUTION1255
68083-141-02Argatroban2 in 1 CARTONSOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-141ARGATROBAN SOLUTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20170526_e5ccb93c-f411-4e7e-824a-4a592b4947ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804737argatroban 125 MG in 125 ML InjectionPSNe5ccb93c-f411-4e7e-824a-4a592b4947ec5
1804737125 ML argatroban 1 MG/ML InjectionSCDe5ccb93c-f411-4e7e-824a-4a592b4947ec5
1804737argatroban 125 MG per 125 ML InjectionSYe5ccb93c-f411-4e7e-824a-4a592b4947ec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-141-0168083014101125 mL in 1 VIAL125 mlHistorical
68083-141-02680830141022 VIAL in 1 CARTON (68083-141-02) / 125 mL in 1 VIAL (68083-141-01) 2 vial2017-05-260000-00-00NoNoCurrent