Articaine Hydrochloride and Epinephrine

Product NDC
72304-016
11-digit product format
723040016
Labeler code
72304
Product ID
72304-016_cfcf8e32-6481-f6be-e053-2995a90acb87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARTICAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Midway Dental Supply, LLC
Application
NDA022466
Marketing category
NDA
Marketing start
2021-04-26
Marketing end
0000-00-00
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72304-016-002023-03-21C16284748780-1f386c64a-3bcf-0266-e053-dadaa90a7c1abe742506-8c6e-6ff2-e053-2995a90a6b21
72304-016-002023-01-30C16284748780-1f386c64a-3bcf-0266-e053-dadaa90a7c1abe742506-8c6e-6ff2-e053-2995a90a6b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72304-016-007230400160050 CARTRIDGE in 1 BOX (72304-016-00) > 1.8 mL in 1 CARTRIDGE50 cartridge2021-04-260000-00-00NoNoCurrent