Sensorcaine

Product NDC
52584-465
11-digit product format
525840465
Labeler code
52584
Product ID
52584-465_3bea6afe-dc78-4db1-9a10-5d454c5ac335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
NDA018304
Marketing category
NDA
Marketing start
2011-10-17
Marketing end
2026-01-31
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
BupivacaineACTIVE MOIETYY8335394ROSENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-465SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]10Legacy NDC20221230_e5808712-4487-43b2-891f-e1ef47a9e28d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-465-57525840465571 VIAL in 1 BAG (52584-465-57) > 50 mL in 1 VIAL1 vial2011-10-170000-00-00NoNoCurrent