FDA.reportPublic FDA data

Argatroban

Product NDC
63323-526
11-digit product format
633230526
Labeler code
63323
Product ID
63323-526_c5ad8f27-49b3-41a1-884f-4e07ffa86558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA201811
Marketing category
NDA
Marketing start
2015-03-23
Substance
ARGATROBAN
Active strength
100 mg/mL
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
ARGATROBAN100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIY90U61Z3S
Rxcui308351

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
63323-526-03Argatroban1 in 1 CARTONINJECTION, SOLUTION110
63323-526-03Argatroban2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2.510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-526-03ML - Milliliter63323-526d47a8d62-7f20-4b05-9d99-e9aa3d5156ff12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARGATROBANACTIVE INGREDIENTIY90U61Z3SARGATROBAN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ARGATROBAN ANHYDROUSACTIVE MOIETYOCY3U280Y3ARGATROBAN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARGATROBAN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-526ARGATROBAN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20241018_e1cf0ad0-0b23-497e-9deb-3de3bf48be44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308351argatroban 250 MG in 2.5 ML InjectionPSNe1cf0ad0-0b23-497e-9deb-3de3bf48be4410
3083512.5 ML argatroban 100 MG/ML InjectionSCDe1cf0ad0-0b23-497e-9deb-3de3bf48be4410
308351argatroban 250 MG per 2.5 ML InjectionSYe1cf0ad0-0b23-497e-9deb-3de3bf48be4410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-526-03633230526031 VIAL, SINGLE-DOSE in 1 CARTON (63323-526-03) > 2.5 mL in 1 VIAL, SINGLE-DOSE2015-03-230000-00-00NoNoCurrent