Prilocaine Hydrochloride with Epinephrine

Product NDC
0362-9013
11-digit product format
003629013
Labeler code
0362
Product ID
0362-9013_e470f75b-5f30-47a1-886c-be1768920f8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prilocaine and epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Septodont Inc.
Application
ANDA078959
Marketing category
ANDA
Marketing start
2011-09-10
Marketing end
0000-00-00
Substance
PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40 mg/mL; mg/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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0362-9013-502019-10-29C16284748780-1960f7f55-daff-8e05-e053-dbdaa90a074ab374a5f1-ef37-402d-b011-ca8d20689f02