Bivalirudin

Product NDC
70860-403
11-digit product format
708600403
Labeler code
70860
Product ID
70860-403_e670c25e-1572-4492-a6b5-4f42ba4b389a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
NDA211215
Marketing category
NDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
BIVALIRUDIN
Active strength
5 mg/mL
Pharmacologic classes
Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-403-512024-03-02C16284748780-11030e365-5946-111a-e063-dadaa90a10e21ed8c822-6fe1-49c1-a59f-31a4c72818c8
70860-403-512024-01-30C16284748780-11030e365-5946-111a-e063-dadaa90a10e21ed8c822-6fe1-49c1-a59f-31a4c72818c8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-403-50ML - Milliliter70860-4036b458038-5c20-427d-9e96-893b2c7c354712020-03-10
70860-403-51ML - Milliliter70860-403311de9e9-6aaf-4720-aadc-2eeec21a9f0612020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-403-517086004035110 CARTON in 1 CARTON (70860-403-51) > 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-403-50) > 50 mL in 1 VIAL, SINGLE-DOSE10 carton2020-03-010000-00-00NoNoCurrent