FDA.reportPublic FDA data

Ultacan Forte

Product NDC
52120-100
11-digit product format
521200100
Labeler code
52120
Product ID
52120-100_85dfc4ff-e676-4dac-9dd8-63c15af9842c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
articaine hydrochloride, epinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
HANSAmed, Inc.
Application
ANDA201750
Marketing category
ANDA
Marketing start
2017-07-11
Marketing end
0000-00-00
Substance
ARTICAINE 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
2018-12-31
Current FDA listing
Historical FDA.report record

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52120-100-012020-01-31C16284748780-19d75b9d0-085c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000
52120-100-052020-01-31C16284748780-19d75b9d0-085c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000
52120-100-102020-01-31C16284748780-19d75b9d0-085c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Ultacan® and Ultacan® forte safely and effectively. See full prescribing information for Ultacan® and Ultacan® forte. Ultacan® and Ultacan® forte (Articaine HCl 4% and epinephrine Injection, USP); Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52120-100-00Ultacan Forte1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71
52120-100-01Ultacan Forte10 in 1 BOXINJECTION, SOLUTION101
52120-100-05Ultacan Forte50 in 1 BOXINJECTION, SOLUTION501
52120-100-10Ultacan Forte100 in 1 BOXINJECTION, SOLUTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52120-100ULTACAN (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION ULTACAN FORTE (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HANSAMED, INC.]1Legacy NDC, 4 package rows20170720_e005e3da-142d-4eba-a0c0-35e05b234130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928862articaine hydrochloride 40 MG / EPINEPHrine bitartrate 1:100,000 in 1.7 ML CartridgePSNe005e3da-142d-4eba-a0c0-35e05b2341301
1928853articaine hydrochloride 40 MG / EPINEPHrine bitartrate 1:200,000 in 1.7 ML CartridgePSNe005e3da-142d-4eba-a0c0-35e05b2341301
1928858Ultacan 40 MG / 1:200,000 in 1.7 ML CartridgePSNe005e3da-142d-4eba-a0c0-35e05b2341301
1928864Ultacan forte 40 MG / 1:100,000 in 1.7 ML CartridgePSNe005e3da-142d-4eba-a0c0-35e05b2341301
19288581.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.009 MG/ML Cartridge [Ultacan]SBDe005e3da-142d-4eba-a0c0-35e05b2341301
19288641.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.018 MG/ML Cartridge [Ultacan]SBDe005e3da-142d-4eba-a0c0-35e05b2341301
19288531.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.009 MG/ML CartridgeSCDe005e3da-142d-4eba-a0c0-35e05b2341301
19288621.7 ML articaine hydrochloride 40 MG/ML / epinephrine bitartrate 0.018 MG/ML CartridgeSCDe005e3da-142d-4eba-a0c0-35e05b2341301
1928853articaine hydrochloride 40 MG / epinephrine bitartrate 0.009 MG per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928862articaine hydrochloride 40 MG / epinephrine bitartrate 0.018 MG per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928862articaine hydrochloride 40 MG / epinephrine bitartrate 1:100,000 per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928853articaine hydrochloride 40 MG / epinephrine bitartrate 1:200,000 per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928858Ultacan 40 MG / 0.009 MG per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928864Ultacan 40 MG / 0.018 MG per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928864Ultacan 40 MG / 1:100,000 per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301
1928858Ultacan 40 MG / 1:200,000 per 1.7 ML CartridgeSYe005e3da-142d-4eba-a0c0-35e05b2341301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52120-100-00521200100001.7 mL in 1 CARTRIDGE1.7 mlHistorical
52120-100-015212001000110 in 1 BOXHistorical
52120-100-055212001000550 in 1 BOXHistorical
52120-100-1052120010010100 in 1 BOXHistorical