Articaine Hydrochloride and Epinephrine

Product NDC: 43498-993
Requested package NDC: 43498-993-01
11-digit product format: 434980993
Labeler code: 43498
Product ID: 43498-993_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; 5 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43498-993	43498-993-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43498-993	43498-993-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`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	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	5 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f11bb06-c71b-4d96-9baa-2a17ad473a05	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43498-993-01	Articaine Hydrochloride and Epinephrine	50 in 1 BOX	INJECTION, SOLUTION	50		4
43498-993-01	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
43498-993	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE	Burkhart Dental Supply Co., Inc	4f11bb06-c71b-4d96-9baa-2a17ad473a05	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022466 application number: NDA022466 ndc (package): 43498-993-01 ndc (product): 43498-993 ndc11 (package): 43498099301
Articaine HCl and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Safco Dental Supply Co.	0536a4de-578d-497e-a01b-0b1887344cc8	2023-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022466 application number: NDA022466
Orabloc	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Pierrel S.p.A.	d18424f0-a691-11dd-ad8b-0800200c9a66	2018-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022466 application number: NDA022466

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QS9014Q792	ARTICAINE HYDROCHLORIDE	23964-57-0	ARTICAINE HYDROCHLORIDE
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

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	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4
1658966	articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 mL Dental Cartridge	PSN	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4
1658966	1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge	SCD	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4
1661483	1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge	SCD	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4
1661483	articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental Cartridge	SY	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4
1658966	articaine HCl 4 % / epinephrine 1:200,000 1.8 ML Cartridge	SY	4f11bb06-c71b-4d96-9baa-2a17ad473a05	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43498-993-01	43498099301	50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE	50 cartridge	2024-11-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Articaine Hydrochloride and Epinephrine	Burkhart Dental Supply Co., Inc \| Pierrel S.p.A.	2024-11-18	HUMAN PRESCRIPTION DRUG LABEL	4