Bupivacaine Hydrochloride and Epinephrine

Product NDC
52584-042
11-digit product format
525840042
Labeler code
52584
Product ID
52584-042_799eebf4-53cc-404f-bd27-9857b2471cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA071165
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
3 mg/mL; ug/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-042-17525840042171 VIAL, SINGLE-DOSE in 1 BAG (52584-042-17) > 30 mL in 1 VIAL, SINGLE-DOSE2016-09-220000-00-00NoNoCurrent