Angiomax

Product NDC
0781-3447
11-digit product format
007813447
Labeler code
0781
Product ID
0781-3447_eddac8ab-ef06-4517-bbed-7ac30cc73df3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA020873
Marketing category
NDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
BIVALIRUDIN
Active strength
250 mg/1
Pharmacologic classes
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3447-95EA - Each0781-34473dbcb731-c8e5-43b0-9b50-57c3f383c5fc12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3447ANGIOMAX (BIVALIRUDIN) INJECTION [SANDOZ INC]2Legacy NDC20221130_5f133813-f74e-4508-bc64-debbf104ff1e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3447-950078134479510 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) > 1 INJECTION in 1 VIAL, SINGLE-USE2019-08-010000-00-00NoNoCurrent