Isocaine
Name: Isocaine
PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton
NRG
Distributed by IQ Dental
NDC 51004-2020-5
MEPIVACAINE HCl 3%
INJECTION
without VASOCONSTRICTOR
(MEPIVACAINE HCl INJECTION, USP)
50 Cartridges • 1.7 mL Minimum
Rx Only
iQDental™
Isocaine mepivacaine hydrochloride injection, solution |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:51004-2020 | | Route of Administration | SUBCUTANEOUS | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Mepivacaine Hydrochloride (Mepivacaine) | Mepivacaine Hydrochloride | 30 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | Sodium Chloride | 6 mg in 1 mL | | Water | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:51004-2020-5 | 50 CARTRIDGE (CARTRIDGE) in 1 CARTON | | 1 | | 1.7 mL in 1 CARTRIDGE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | ANDA | ANDA088387 | 08/20/2010 | | |
| Labeler - Novocol Pharmaceutical of Canada, Inc. (201719960) |
| Registrant - IQ Dental (800349763) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Novocol | | 201719960 | MANUFACTURE |
Revised: 07/2010 Novocol Pharmaceutical of Canada, Inc.