Articadent

Product NDC: 66312-602
11-digit product format: 663120602
Labeler code: 66312
Product ID: 66312-602_7b56ec0a-5b85-4069-a3b2-94654644aaa4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Articaine hydrochloride and Epinephrine Bitartrate
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: Dentsply Pharmaceutical
Application: NDA020971
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-09-01
Substance: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 40; .005 mg/mL; mg/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
N020971-001	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03
N020971-002	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30

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.

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
2026-08-01 22:54:32	2026-06	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	636cbf11-819c-48f8-915d-ac5fb38bd352	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Septocaine and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Septodont Inc.	0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	fc908011-5e5e-459a-a666-d41426504703	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Zorcaine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	1767d606-69b8-419e-840f-36550ed91b8f	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	2b5a7ee3-71ee-4c41-ad9f-852f170470b3	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	0b0cbbec-8216-434f-892e-226c89d7239c	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	cc7ff594-2204-44b2-8f81-bcb9c7e9360b	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	f26a084b-ab25-4ca2-8f58-705a4219bf32	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	406de6e6-40f5-44c5-a109-3be0b9d48e58	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	d47d7842-930e-41db-9631-d1aba0f05ae0	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein	d9402ac2-fedd-4fb0-90a3-2c466a786526	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Articadent	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 66312-602
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	c4bba4ab-2b20-43e6-92ea-9ec6f1fce754	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	854399ec-f7d6-4eab-87bb-94c2b442ec3e	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	4524cb96-40f7-471f-bfc6-1dcab47628ec	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971

Additional Listing Data#

Finished product: Yes
Brand name base: Articadent
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL
EPINEPHRINE BITARTRATE	.005 mg/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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011646	Internal RxNorm lookup
1011648	Internal RxNorm lookup
1595029	Internal RxNorm lookup
1595035	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
9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	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
66312-602-16	Articadent	1.7 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1.7		9
66312-602-16	Articadent	50 in 1 CARTON	INJECTION, SOLUTION	50		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66312-602-16	ML - Milliliter	66312-602	fb6418a4-a332-4f65-906c-dcddf26be275	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Articaine hydrochloride	ACTIVE INGREDIENT	QS9014Q792	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Epinephrine Bitartrate	ACTIVE INGREDIENT	30Q7KI53AK	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Articaine	ACTIVE MOIETY	D3SQ406G9X	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Epinephrine	ACTIVE MOIETY	YKH834O4BH	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66312-602	ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL]	9	Current NDC, Legacy NDC, 2 package rows	20240302_9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00.zip

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
1011648	Articadent 4 % / 1:100,000 in 1.7 mL Dental Cartridge	PSN	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011646	Articadent 4 % / 1:200,000 in 1.7 mL Dental Cartridge	PSN	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595035	articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge	PSN	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595029	articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental Cartridge	PSN	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011646	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge [Articadent]	SBD	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011648	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Articadent]	SBD	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595029	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge	SCD	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595035	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge	SCD	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011648	Articadent (articaine HCl 4 % / epinephrine 1:100,000) 1.7 ML Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011648	Articadent 4 % / 1:100,000 in 1.7 mL Dental Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011646	Articadent 4 % / 1:200,000 (articaine HCl / epinephrine (as epinephrine bitartrate)) 1.7 ML Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1011646	Articadent 4 % with epinephrine 1:200,000 1.7 ML Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595035	articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595035	articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9
1595029	articaine HCl 4 % / epinephrine 1:200,000 1.7 ML Cartridge	SY	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66312-602-16	66312060216	50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE	50 cartridge	2009-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Articadent	Dentsply Pharmaceutical \| Novocol Pharmaceutical of Canada, Inc.	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	9