FDA.reportPublic FDA data

Citanest Forte DENTAL

Product NDC
66312-580
11-digit product format
663120580
Labeler code
66312
Product ID
66312-580_9ea4e9ed-3979-422b-b516-6b3c32459a62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prilocaine hcl and epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Dentsply Pharmaceutical 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citanest Forte DENTAL
Listing expiration
2026-12-31

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
66312-580-16Citanest Forte DENTAL50 in 1 CARTONINJECTION, SOLUTION507
66312-580-16Citanest Forte DENTAL1.8 mL in 1 CARTRIDGEINJECTION, SOLUTION1.87

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66312-580CITANEST FORTE DENTAL (PRILOCAINE HCL AND EPINEPHRINE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.]7Current NDC, Legacy NDC, 2 package rows20240302_60c8710b-ae55-4fdf-e053-2991aa0adc75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1993224Citanest Forte 4 % / 1:200,000 in 1.8 ML CartridgePSN60c8710b-ae55-4fdf-e053-2991aa0adc757
1596950prilocaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 ML CartridgePSN60c8710b-ae55-4fdf-e053-2991aa0adc757
19932241.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML Cartridge [Citanest Forte]SBD60c8710b-ae55-4fdf-e053-2991aa0adc757
15969501.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML CartridgeSCD60c8710b-ae55-4fdf-e053-2991aa0adc757
1993224Citanest Forte (prilocaine HCl 4 % / epineprine (as epinephrine bitartrate) 1:200,000) in 1.8 ML CartridgeSY60c8710b-ae55-4fdf-e053-2991aa0adc757
1993224Citanest Forte 4 % / 1:200,000 in 1.8 ML CartridgeSY60c8710b-ae55-4fdf-e053-2991aa0adc757
1596950epinephrine 1:200,000 / prilocaine HCl 4 % 1.8 ML CartridgeSY60c8710b-ae55-4fdf-e053-2991aa0adc757
1596950prilocaine HCl 4 % / epinephrine (as epinephrine bitartrate) 1:200,000 in 1.8 ML CartridgeSY60c8710b-ae55-4fdf-e053-2991aa0adc757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66312-580-166631205801650 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE50 cartridge2017-12-040000-00-00NoNoCurrent