Articaine Hydrochloride and Epinephrine

Product NDC
51004-6620
11-digit product format
510046620
Labeler code
51004
Product ID
51004-6620_790f8c36-8777-46b2-a3aa-eaa505695d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Articaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Novocol Pharmaceutical of Canada, Inc.
Application
NDA020971
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-28
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; .01 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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020971-001SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03
N020971-002SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30

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.

Product history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONAPRLD, RS2000-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0387673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020971-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020971-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N020971-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020971-001AP1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Articaine Hydrochloride and Epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL
EPINEPHRINE BITARTRATE.01 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QS9014Q792Internal UNII lookup
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1595029Internal RxNorm lookup
1595035Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636cbf11-819c-48f8-915d-ac5fb38bd352Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51004-6620-5Articaine Hydrochloride and Epinephrine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71
51004-6620-5Articaine Hydrochloride and Epinephrine50 in 1 CARTONINJECTION, SOLUTION501

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.636cbf11-819c-48f8-915d-ac5fb38bd3522026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ndc (product): 51004-6620
Septocaine and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont Inc.0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce032024-10-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.fc908011-5e5e-459a-a666-d414265047032024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ZorcaineARTICAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.1767d606-69b8-419e-840f-36550ed91b8f2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental2b5a7ee3-71ee-4c41-ad9f-852f170470b32024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.0b0cbbec-8216-434f-892e-226c89d7239c2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.cc7ff594-2204-44b2-8f81-bcb9c7e9360b2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.f26a084b-ab25-4ca2-8f58-705a4219bf322024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental406de6e6-40f5-44c5-a109-3be0b9d48e582024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dentald47d7842-930e-41db-9631-d1aba0f05ae02024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINEHenry Scheind9402ac2-fedd-4fb0-90a3-2c466a7865262024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ArticadentARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical9ca8fb43-4f34-47c0-8b79-3b5bd1eaee002024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.c4bba4ab-2b20-43e6-92ea-9ec6f1fce7542024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.854399ec-f7d6-4eab-87bb-94c2b442ec3e2024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dental4524cb96-40f7-471f-bfc6-1dcab47628ec2024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595035articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental CartridgePSN636cbf11-819c-48f8-915d-ac5fb38bd3521
1595029articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental CartridgePSN636cbf11-819c-48f8-915d-ac5fb38bd3521
15950291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD636cbf11-819c-48f8-915d-ac5fb38bd3521
15950351.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML CartridgeSCD636cbf11-819c-48f8-915d-ac5fb38bd3521
1595035articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521
1595035articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521
1595029articaine HCl 4 % / epinephrine 1:200,000 1.7 ML CartridgeSY636cbf11-819c-48f8-915d-ac5fb38bd3521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51004-6620-55100466200550 CARTRIDGE in 1 CARTON (51004-6620-5) / 1.7 mL in 1 CARTRIDGE50 cartridge2015-01-28NoNoCurrent