Argatroban

Product NDC
87188-104
11-digit product format
871880104
Labeler code
87188
Product ID
87188-104_514ad16d-9f31-7808-e063-6394a90a1151
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Plano Pharmaceuticals Inc.
Application
NDA022485
Marketing category
NDA
Marketing start
2011-05-09
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
87188-104-01Argatroban125 mL in 1 VIAL, SINGLE-USESOLUTION1251
87188-104-90Argatroban2 in 1 CARTONSOLUTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804737argatroban 125 MG in 125 ML InjectionPSN514ad15b-d060-9d65-e063-6294a90a61881
1804737125 ML argatroban 1 MG/ML InjectionSCD514ad15b-d060-9d65-e063-6294a90a61881
1804737argatroban 125 MG per 125 ML InjectionSY514ad15b-d060-9d65-e063-6294a90a61881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87188-104-0187188010401125 mL in 1 VIAL, SINGLE-USE125 mlHistorical
87188-104-90871880104902 VIAL, SINGLE-USE in 1 CARTON (87188-104-90) / 125 mL in 1 VIAL, SINGLE-USE (87188-104-01) 2011-05-09NoNoHistorical