Home NDC 43498-816 Articaine Hydrochloride and Epinephrine
Product NDC 43498-816
11-digit product format 434980816
Labeler code 43498
Product ID 43498-816_644fa9c3-1491-42e3-9194-9c562617fd06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler Burkhart Dental Supply Co., Inc
Application NDA022466
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-11-04
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43498-816-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43498-816-01 557ba5c1ecfa…9c80585c8c6e…
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 Articaine Hydrochloride and Epinephrine
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 QS9014Q792 Internal UNII lookup 30Q7KI53AK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43498-816-01 Articaine Hydrochloride and Epinephrine 50 in 1 BOX INJECTION, SOLUTION 50 4 43498-816-01 Articaine Hydrochloride and Epinephrine 1.8 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.8 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43498-816 ARTICAINE HYDROCHLORIDE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [BURKHART DENTAL SUPPLY CO., INC] 4 Current NDC, 2 package rows 20241120_4f11bb06-c71b-4d96-9baa-2a17ad473a05.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43498-816-01 43498081601 50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE 50 cartridge 2024-11-04 No No Current