orabloc

Generic: articaine hydrochloride and epinephrine bitartrate

Labeler: pierrel s.p.a.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orabloc
Generic Name articaine hydrochloride and epinephrine bitartrate
Labeler pierrel s.p.a.
Dosage Form INJECTION
Routes
SUBMUCOSAL
Active Ingredients

articaine hydrochloride 40 mg/mL, epinephrine bitartrate 10 ug/mL

Manufacturer
Pierrel S.p.A.

Identifiers & Regulatory

Product NDC 45146-110
Product ID 45146-110_df09bf36-46b3-4edf-9a11-9d12bb7e12b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022466
Listing Expiration 2026-12-31
Marketing Start 2011-03-01

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45146110
Hyphenated Format 45146-110

Supplemental Identifiers

RxCUI
1091068 1091072 1658966 1661483
UNII
30Q7KI53AK QS9014Q792

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orabloc (source: ndc)
Generic Name articaine hydrochloride and epinephrine bitartrate (source: ndc)
Application Number NDA022466 (source: ndc)
Routes
SUBMUCOSAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
  • 10 ug/mL
source: ndc
Packaging
  • 100 CARTRIDGE in 1 BOX (45146-110-01) / 1.8 mL in 1 CARTRIDGE
  • 50 CARTRIDGE in 1 BOX (45146-110-02) / 1.8 mL in 1 CARTRIDGE
source: ndc

Packages (2)

45146-110-01 100 CARTRIDGE in 1 BOX (45146-110-01) / 1.8 mL in 1 CARTRIDGE 45146-110-02 50 CARTRIDGE in 1 BOX (45146-110-02) / 1.8 mL in 1 CARTRIDGE

Ingredients (2)

articaine hydrochloride (40 mg/mL) epinephrine bitartrate (10 ug/mL)

Linked Drug Pages (1)

Orabloc ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBMUCOSAL"], "spl_id": "df09bf36-46b3-4edf-9a11-9d12bb7e12b3", "openfda": {"unii": ["30Q7KI53AK", "QS9014Q792"], "rxcui": ["1091068", "1091072", "1658966", "1661483"], "spl_set_id": ["d18424f0-a691-11dd-ad8b-0800200c9a66"], "manufacturer_name": ["Pierrel S.p.A."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CARTRIDGE in 1 BOX (45146-110-01)  / 1.8 mL in 1 CARTRIDGE", "package_ndc": "45146-110-01", "marketing_start_date": "20110301"}, {"sample": false, "description": "50 CARTRIDGE in 1 BOX (45146-110-02)  / 1.8 mL in 1 CARTRIDGE", "package_ndc": "45146-110-02", "marketing_start_date": "20110301"}], "brand_name": "Orabloc", "product_id": "45146-110_df09bf36-46b3-4edf-9a11-9d12bb7e12b3", "dosage_form": "INJECTION", "pharm_class": ["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]"], "product_ndc": "45146-110", "generic_name": "articaine hydrochloride and epinephrine bitartrate", "labeler_name": "Pierrel S.p.A.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orabloc", "active_ingredients": [{"name": "ARTICAINE HYDROCHLORIDE", "strength": "40 mg/mL"}, {"name": "EPINEPHRINE BITARTRATE", "strength": "10 ug/mL"}], "application_number": "NDA022466", "marketing_category": "NDA", "marketing_start_date": "20110301", "listing_expiration_date": "20261231"}