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 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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d18424f0-a691-11dd-ad8b-0800200c9a66	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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45146-110-02	ML - Milliliter	45146-110	30d8dbc3-2d88-4124-8e45-edd2d24c2d2b	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARTICAINE HYDROCHLORIDE	ACTIVE INGREDIENT	QS9014Q792	ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]	16
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]	16
ARTICAINE	ACTIVE MOIETY	D3SQ406G9X	ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]	16
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	ORABLOC (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [PIERREL S.P.A.]	16

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.

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 ndc (product): 45146-110

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	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