Bivalirudin

Product NDC
70860-402
11-digit product format
708600402
Labeler code
70860
Product ID
70860-402_556410e5-3149-4de4-8bea-aa90b7df437d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA210031
Marketing category
ANDA
Marketing start
2019-11-30
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-402-102024-03-02C16284748780-11030e365-03f8-111a-e063-dadaa90a10e265b6f8fc-ae1f-45d6-9b7a-8bb3cc279f8f
70860-402-102024-01-30C16284748780-11030e365-03f8-111a-e063-dadaa90a10e265b6f8fc-ae1f-45d6-9b7a-8bb3cc279f8f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-402-10EA - Each70860-4028390ce33-5973-494b-954d-4ae0e35b00da12020-01-03
70860-402-41EA - Each70860-402ae3fcbf3-8a09-4067-bfaf-4c1eb57cf97312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-402BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]2Legacy NDC20240304_65b6f8fc-ae1f-45d6-9b7a-8bb3cc279f8f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-402-107086004021010 VIAL, SINGLE-DOSE in 1 CARTON (70860-402-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70860-402-41) 2019-11-300000-00-00NoNoCurrent