FDA.reportPublic FDA data

Orabloc

Product NDC
45146-110
11-digit product format
451460110
Labeler code
45146
Product ID
45146-110_df09bf36-46b3-4edf-9a11-9d12bb7e12b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
articaine hydrochloride and epinephrine bitartrate
Dosage form
INJECTION
Route
SUBMUCOSAL
Labeler
Pierrel S.p.A.
Application
NDA022466
Marketing category
NDA
Marketing start
2011-03-01
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; 10 mg/mL; ug/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
Orabloc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL
EPINEPHRINE BITARTRATE10 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQS9014Q792, 30Q7KI53AK
Rxcui1091068, 1091072, 1658966, 1661483

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45146-110-01Orabloc1.8 mL in 1 CARTRIDGEINJECTION1.820
45146-110-01Orabloc100 in 1 BOXINJECTION10020
45146-110-02Orabloc50 in 1 BOXINJECTION5020
45146-110-02Orabloc1.8 mL in 1 CARTRIDGEINJECTION1.820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45146-110-02ML - Milliliter45146-11030d8dbc3-2d88-4124-8e45-edd2d24c2d2b12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARTICAINE HYDROCHLORIDEACTIVE INGREDIENTQS9014Q792ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]16
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]16
ARTICAINEACTIVE MOIETYD3SQ406G9XORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]16
EPINEPHRINEACTIVE MOIETYYKH834O4BHORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45146-110ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]20Current NDC, Legacy NDC, 4 package rows20190423_d18424f0-a691-11dd-ad8b-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661483articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgePSNd18424f0-a691-11dd-ad8b-0800200c9a6620
1658966articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental CartridgePSNd18424f0-a691-11dd-ad8b-0800200c9a6620
1091068Orabloc 4 % / 1:100,000 in 1.8 mL Dental CartridgePSNd18424f0-a691-11dd-ad8b-0800200c9a6620
1091072Orabloc 4 % / 1:200,000 in 1.8 mL Dental CartridgePSNd18424f0-a691-11dd-ad8b-0800200c9a6620
10910721.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Orabloc]SBDd18424f0-a691-11dd-ad8b-0800200c9a6620
10910681.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]SBDd18424f0-a691-11dd-ad8b-0800200c9a6620
16589661.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCDd18424f0-a691-11dd-ad8b-0800200c9a6620
16614831.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCDd18424f0-a691-11dd-ad8b-0800200c9a6620
1661483articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental CartridgeSYd18424f0-a691-11dd-ad8b-0800200c9a6620
1658966articaine HCl 4 % / epinephrine 1:200,000 1.8 ML CartridgeSYd18424f0-a691-11dd-ad8b-0800200c9a6620
1091068Orabloc 4 % / 1:100,000 in 1.8 mL Dental CartridgeSYd18424f0-a691-11dd-ad8b-0800200c9a6620
1091072Orabloc 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.8 ML CartridgeSYd18424f0-a691-11dd-ad8b-0800200c9a6620
1091072Orabloc 4 % with epinephrine 1:200,000 1.8 ML CartridgeSYd18424f0-a691-11dd-ad8b-0800200c9a6620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45146-110-0145146011001100 CARTRIDGE in 1 BOX (45146-110-01) / 1.8 mL in 1 CARTRIDGE100 cartridge2011-03-010000-00-00NoNoCurrent
45146-110-024514601100250 CARTRIDGE in 1 BOX (45146-110-02) / 1.8 mL in 1 CARTRIDGE50 cartridge2011-03-010000-00-00NoNoCurrent