FDA.reportPublic FDA data

Bivalirudin

Product NDC
42023-622
11-digit product format
420230622
Labeler code
42023
Product ID
42023-622_e7641caf-d2f1-4a0e-a559-cd14aed68548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bivalirudin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Endo USA, Inc.
Application
NDA211215
Marketing category
NDA
Marketing start
2023-06-19
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
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTN9BEX005G
Rxcui1997015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
1c25cd48-e81c-4683-ac07-71f9a642e2bfProduct name920211217
325b79a5-b460-45d7-abfc-c4784f5b0531Product name120191120
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c3370853-5a7f-4c73-a273-26ef0162f2f3Product name120180308
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-622-01Bivalirudin1 in 1 CARTONINJECTION, SOLUTION12
42023-622-01Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
42023-622-10Bivalirudin1 in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
42023-622-10Bivalirudin10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-622-01ML - Milliliter42023-6222d4d8b55-5acb-442c-84b6-be8abe39719d12023-08-08
42023-622-10ML - Milliliter42023-6229033ac46-495b-430f-b89b-b34ec1f52ce112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-622BIVALIRUDIN INJECTION, SOLUTION [ENDO USA, INC.]2Current NDC, 4 package rows20241031_91cf9d00-29e0-4357-a184-f70026c47edb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1997015bivalirudin 250 MG in 50 ML InjectionPSN91cf9d00-29e0-4357-a184-f70026c47edb2
199701550 ML bivalirudin 5 MG/ML InjectionSCD91cf9d00-29e0-4357-a184-f70026c47edb2
1997015bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 50 ML InjectionSY91cf9d00-29e0-4357-a184-f70026c47edb2
1997015bivalirudin 250 MG per 50 ML InjectionSY91cf9d00-29e0-4357-a184-f70026c47edb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42023-622-01420230622011 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE2023-06-19NoNoHistorical
42023-622-104202306221010 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE2023-06-19NoNoHistorical