FDA.reportPublic FDA data

Argatroban

Product NDC
42023-182
11-digit product format
420230182
Labeler code
42023
Product ID
42023-182_1494b62a-dded-4fde-b926-203b281e37ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
ANDA091665
Marketing category
ANDA
Marketing start
2015-06-01
Substance
ARGATROBAN
Active strength
250 mg/2.5mL
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
ARGATROBAN250 mg/2.5mL

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-182-89Argatroban2.5 mL in 1 VIALINJECTION2.512
42023-182-89Argatroban1 in 1 CARTONINJECTION112
42023-182-01Argatroban1 in 1 CARTONINJECTION110
42023-182-01Argatroban2.5 mL in 1 VIALINJECTION2.510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-182-01ML - Milliliter42023-182819d7f1b-1222-4751-9af4-e15bb89a259612015-08-04
42023-182-89ML - Milliliter42023-1823972d605-bd35-4443-973d-61a70b144dd212023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARGATROBANACTIVE INGREDIENTIY90U61Z3SARGATROBAN INJECTION [PAR PHARMACEUTICAL, INC.]2
ARGATROBAN ANHYDROUSACTIVE MOIETYOCY3U280Y3ARGATROBAN INJECTION [PAR PHARMACEUTICAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MARGATROBAN INJECTION [PAR PHARMACEUTICAL, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RARGATROBAN INJECTION [PAR PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-182ARGATROBAN INJECTION [ENDO USA, INC.]10Current NDC, Legacy NDC, 2 package rows20240913_1a67a87d-59cb-414c-a11e-ab8f0a9bb778.zip
42023-182ARGATROBAN INJECTION [ENDO USA, INC.]8Current NDC, Legacy NDC, 2 package rows20240913_d4e5238f-2378-424e-bda2-f1a2cf874041.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308351argatroban 250 MG in 2.5 ML InjectionPSN1a67a87d-59cb-414c-a11e-ab8f0a9bb77812
3083512.5 ML argatroban 100 MG/ML InjectionSCD1a67a87d-59cb-414c-a11e-ab8f0a9bb77812
308351argatroban 250 MG per 2.5 ML InjectionSY1a67a87d-59cb-414c-a11e-ab8f0a9bb77812
308351argatroban 250 MG in 2.5 ML InjectionPSNd4e5238f-2378-424e-bda2-f1a2cf87404110
3083512.5 ML argatroban 100 MG/ML InjectionSCDd4e5238f-2378-424e-bda2-f1a2cf87404110
308351argatroban 250 MG per 2.5 ML InjectionSYd4e5238f-2378-424e-bda2-f1a2cf87404110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-182-01420230182011 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL1 vial2015-06-010000-00-00NoNoCurrent
42023-182-89420230182891 VIAL in 1 CARTON (42023-182-89) / 2.5 mL in 1 VIAL1 vial2015-06-01NoNoHistorical