Bivalirudin in 0.9% Sodium Chloride

Product NDC
0338-9572
11-digit product format
003389572
Labeler code
0338
Product ID
0338-9572_68a6b49d-9eb8-4d19-9b4a-41f17572b438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bivalirudin in 0.9% Sodium Chloride Injection
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA208374
Marketing category
NDA
Marketing start
2017-12-21
Marketing end
0000-00-00
Substance
BIVALIRUDIN
Active strength
250 mg/50mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0338-9572-242022-10-27C16284748780-1e4f33bdf-b1d1-d8a0-e053-dadaa90a6e4ee082d38c-3efa-4a63-8b22-20d389e78ca3
0338-9572-242022-07-29C16284748780-1e4f33bdf-b1d1-d8a0-e053-dadaa90a6e4ee082d38c-3efa-4a63-8b22-20d389e78ca3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9572-24ML - Milliliter0338-9572e5c29de3-d070-4901-8442-fc72261d034a12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9572-240033895722424 BAG in 1 CARTON (0338-9572-24) > 50 mL in 1 BAG24 bag2017-12-210000-00-00NoNoCurrent