Articaine Hydrochloride and Epinephrine

Product NDC: 72304-015
11-digit product format: 723040015
Labeler code: 72304
Product ID: 72304-015_cfcf8e32-6481-f6be-e053-2995a90acb87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: Midway Dental Supply, LLC
Application: NDA022466
Marketing category: NDA
Marketing start: 2021-04-26
Marketing end: 0000-00-00
Substance: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 40 mg/mL; ug/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72304-015		D	Discontinued by firm		2026-08-10
excluded package	package	72304-015	72304-015-00	D	Discontinued by firm		2026-08-10

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72304-015-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72304-015-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72304-015-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72304-015-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72304-015-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72304-015-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72304-015-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72304-015-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72304-015-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72304-015-00	`ad56d346431e…`	`cc804d4bbf1e…`
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	72304-015-00	`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	72304-015-00	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N022466-001	ORABLOC	4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION	RLD	2010-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022466-002	ORABLOC	4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2010-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022466-001	ORABLOC	4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION	RLD	2010-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022466-002	ORABLOC	4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION	RLD, RS	2010-02-26	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72304-015-00	2023-03-21	C162847	48780-1	f386c64a-3bcf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine Hydrochloride 4% and Epinephrine 1:100,000 Injection Articaine Hydrochloride 4% and Epinephrine 1:200,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000
72304-015-00	2023-01-30	C162847	48780-1	f386c64a-3bcf-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine Hydrochloride 4% and Epinephrine 1:100,000 Injection Articaine Hydrochloride 4% and Epinephrine 1:200,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72304-015-00	72304001500	50 CARTRIDGE in 1 BOX (72304-015-00) > 1.8 mL in 1 CARTRIDGE	50 cartridge	2021-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Articaine Hydrochloride and Epinephrine	Midway Dental Supply, LLC	2022-12-12	HUMAN PRESCRIPTION DRUG LABEL	5