Argatroban

Product NDC
0781-3314
11-digit product format
007813314
Labeler code
0781
Product ID
0781-3314_43e10c0b-2692-4716-8976-ffd73efaf3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Argatroban
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA022434
Marketing category
NDA
Marketing start
2011-09-06
Marketing end
0000-00-00
Substance
ARGATROBAN
Active strength
1 mg/mL
Pharmacologic classes
Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3314-91ML - Milliliter0781-3314166a03c4-03d3-4536-916e-cddc5bfccd9912014-06-03
0781-3314-95ML - Milliliter0781-3314420d70c8-1e24-4f40-95ae-6117c948e16312013-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3314-950078133149510 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE10 carton2017-02-030000-00-00NoNoCurrent