Bupivacaine Hydrochloride

Product NDC
52584-160
11-digit product format
525840160
Labeler code
52584
Product ID
52584-160_3dbb9b88-8e63-4bd3-818e-0b2751337283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA070590
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
2024-02-01
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-160-01525840160011 VIAL, MULTI-DOSE in 1 BAG (52584-160-01) > 50 mL in 1 VIAL, MULTI-DOSE2016-09-090000-00-00NoNoCurrent