Xylocaine

Product NDC
76478-479
11-digit product format
764780479
Labeler code
76478
Product ID
76478-479_1ee8b5fb-2d15-4943-9c9d-3107c6a45b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)
Application
NDA008816
Marketing category
NDA
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76478-479-05764780479051 TUBE in 1 CARTON (76478-479-05) > 5 mL in 1 TUBE1 tube2012-07-010000-00-00NoNoCurrent
76478-479-30764780479301 TUBE in 1 CARTON (76478-479-30) > 30 mL in 1 TUBE1 tube2012-07-010000-00-00NoNoCurrent