Product NDC: | 0362-9049 |
Proprietary Name: | Septocaine and Epinephrine |
Non Proprietary Name: | Articaine Hydrochloride and Epinephrine Bitartrate |
Active Ingredient(s): | 40; .01 mg/mL; mg/mL & nbsp; Articaine Hydrochloride and Epinephrine Bitartrate |
Administration Route(s): | SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0362-9049 |
Labeler Name: | Septodont Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020971 |
Marketing Category: | NDA |
Start Marketing Date: | 20110112 |
Package NDC: | 0362-9049-02 |
Package Description: | 50 CARTRIDGE in 1 CARTON (0362-9049-02) > 1.7 mL in 1 CARTRIDGE |
NDC Code | 0362-9049-02 |
Proprietary Name | Septocaine and Epinephrine |
Package Description | 50 CARTRIDGE in 1 CARTON (0362-9049-02) > 1.7 mL in 1 CARTRIDGE |
Product NDC | 0362-9049 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Articaine Hydrochloride and Epinephrine Bitartrate |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | SUBCUTANEOUS |
Start Marketing Date | 20110112 |
Marketing Category Name | NDA |
Labeler Name | Septodont Inc. |
Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
Strength Number | 40; .01 |
Strength Unit | mg/mL; mg/mL |
Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] |