FDA.reportPublic FDA data

Bivalirudin

Product NDC
0409-8300
11-digit product format
004098300
Labeler code
0409
Product ID
0409-8300_cf21ebf8-98ae-4e4d-81d7-cd9886b438fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BIVALIRUDIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA090816
Marketing category
ANDA
Marketing start
2015-10-05
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
0409-8300-10EA - Each0409-83008b09b14a-0165-406e-978c-43d78ec2e14d12015-08-04
0409-8300-15EA - Each0409-8300f33bd043-de9e-41fe-9d30-729c44b927b912015-10-02
0409-8300-20EA - Each0409-83001f64717f-be8c-4a13-8431-e9041fc55d0b12015-08-04
0409-8300-25EA - Each0409-83002d251398-d695-4df9-8004-bd690dd7606212015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-8300-100040983001010 VIAL, SINGLE-DOSE in 1 TRAY (0409-8300-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-8300-20) 2015-07-300000-00-00NoNoCurrent
0409-8300-150040983001510 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-8300-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-8300-25) 2015-10-050000-00-00NoNoCurrent