Home NDC 45146-110 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022466-001 ORABLOC ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 N022466-002 ORABLOC ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Orabloc
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARTICAINE HYDROCHLORIDE 40 mg/mL EPINEPHRINE BITARTRATE 10 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 30Q7KI53AK Internal UNII lookup QS9014Q792 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091068 Internal RxNorm lookup 1091072 Internal RxNorm lookup 1658966 Internal RxNorm lookup 1661483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45146-110-01 Orabloc 1.8 mL in 1 CARTRIDGE INJECTION 1.8 20 45146-110-01 Orabloc 100 in 1 BOX INJECTION 100 20 45146-110-02 Orabloc 50 in 1 BOX INJECTION 50 20 45146-110-02 Orabloc 1.8 mL in 1 CARTRIDGE INJECTION 1.8 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45146-110 ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.] 20 Current NDC, Legacy NDC, 4 package rows 20190423_d18424f0-a691-11dd-ad8b-0800200c9a66.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1661483 articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge PSN d18424f0-a691-11dd-ad8b-0800200c9a66 20 1658966 articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental Cartridge PSN d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091068 Orabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge PSN d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091072 Orabloc 4 % / 1:200,000 in 1.8 mL Dental Cartridge PSN d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091072 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Orabloc] SBD d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091068 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc] SBD d18424f0-a691-11dd-ad8b-0800200c9a66 20 1658966 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge SCD d18424f0-a691-11dd-ad8b-0800200c9a66 20 1661483 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge SCD d18424f0-a691-11dd-ad8b-0800200c9a66 20 1661483 articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental Cartridge SY d18424f0-a691-11dd-ad8b-0800200c9a66 20 1658966 articaine HCl 4 % / epinephrine 1:200,000 1.8 ML Cartridge SY d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091068 Orabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge SY d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091072 Orabloc 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.8 ML Cartridge SY d18424f0-a691-11dd-ad8b-0800200c9a66 20 1091072 Orabloc 4 % with epinephrine 1:200,000 1.8 ML Cartridge SY d18424f0-a691-11dd-ad8b-0800200c9a66 20
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45146-110-01 45146011001 100 CARTRIDGE in 1 BOX (45146-110-01) / 1.8 mL in 1 CARTRIDGE 100 cartridge 2011-03-01 0000-00-00 No No Current 45146-110-02 45146011002 50 CARTRIDGE in 1 BOX (45146-110-02) / 1.8 mL in 1 CARTRIDGE 50 cartridge 2011-03-01 0000-00-00 No No Current