FDA.reportPublic FDA data

Citanest Forte DENTAL

Product NDC
51004-5801
11-digit product format
510045801
Labeler code
51004
Product ID
51004-5801_8f96de1c-fc45-4d2b-963c-1eadf85bd164
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prilocaine hcl and epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Novocol Pharmaceutical of Canada, Inc.
Application
ANDA078959
Marketing category
ANDA
Marketing start
2017-12-04
Substance
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
Active strength
.005; 40 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citanest Forte DENTAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE.005 mg/mL
PRILOCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, MJW015BAPH
Rxcui1596950, 1993224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51004-5801-6Citanest Forte DENTAL1.8 mL in 1 CARTRIDGEINJECTION, SOLUTION1.81
51004-5801-6Citanest Forte DENTAL50 in 1 CARTONINJECTION, SOLUTION501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1993224Citanest Forte 4 % / 1:200,000 in 1.8 ML CartridgePSN801a4f80-397b-46c5-ad3e-a80594e7bda21
1596950prilocaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 ML CartridgePSN801a4f80-397b-46c5-ad3e-a80594e7bda21
19932241.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML Cartridge [Citanest Forte]SBD801a4f80-397b-46c5-ad3e-a80594e7bda21
15969501.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML CartridgeSCD801a4f80-397b-46c5-ad3e-a80594e7bda21
1993224Citanest Forte (prilocaine HCl 4 % / epineprine (as epinephrine bitartrate) 1:200,000) in 1.8 ML CartridgeSY801a4f80-397b-46c5-ad3e-a80594e7bda21
1993224Citanest Forte 4 % / 1:200,000 in 1.8 ML CartridgeSY801a4f80-397b-46c5-ad3e-a80594e7bda21
1596950epinephrine 1:200,000 / prilocaine HCl 4 % 1.8 ML CartridgeSY801a4f80-397b-46c5-ad3e-a80594e7bda21
1596950prilocaine HCl 4 % / epinephrine (as epinephrine bitartrate) 1:200,000 in 1.8 ML CartridgeSY801a4f80-397b-46c5-ad3e-a80594e7bda21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51004-5801-65100458010650 CARTRIDGE in 1 CARTON (51004-5801-6) / 1.8 mL in 1 CARTRIDGE50 cartridge2017-12-04NoNoCurrent