FDA.reportPublic FDA data

Bivalirudin

Product NDC
16729-275
11-digit product format
167290275
Labeler code
16729
Product ID
16729-275_1fbdba30-8018-d7d3-e063-6294a90ae6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bivalirudin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA206551
Marketing category
ANDA
Marketing start
2018-11-07
Substance
BIVALIRUDIN
Active strength
250 mg/5mL
Pharmacologic classes
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bivalirudin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIVALIRUDIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTN9BEX005G
Rxcui308769

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c25cd48-e81c-4683-ac07-71f9a642e2bfProduct name920211217
325b79a5-b460-45d7-abfc-c4784f5b0531Product name120191120
c3370853-5a7f-4c73-a273-26ef0162f2f3Product name120180308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-275-03Bivalirudin5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,57
16729-275-67Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-275-03EA - Each16729-275a65d4a70-faf6-4761-a8fd-3e345e1756d712018-12-13
16729-275-67EA - Each16729-275800e179c-9749-4a97-9a52-04d3e863cd3712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-275BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.]7Current NDC, Legacy NDC, 2 package rows20240816_c20969cb-72d4-469b-9bd8-332250d896c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308769bivalirudin 250 MG InjectionPSNc20969cb-72d4-469b-9bd8-332250d896c37
308769bivalirudin 250 MG InjectionSCDc20969cb-72d4-469b-9bd8-332250d896c37
308769bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML InjectionSYc20969cb-72d4-469b-9bd8-332250d896c37
308769bivalirudin 50 MG/ML InjectionSYc20969cb-72d4-469b-9bd8-332250d896c37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-275-03167290275035 mL in 1 VIAL, SINGLE-USE5 mlHistorical
16729-275-671672902756710 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) 2018-11-070000-00-00NoNoCurrent