Lidocaine

Product NDC
0362-0898
Requested package NDC
0362-0898-05
11-digit product format
003620898
Labeler code
0362
Product ID
0362-0898_addef151-af97-4dca-8652-e835e89a19a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Septodont, Inc.
Application
ANDA088390
Marketing category
ANDA
Marketing start
2018-07-18
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength
.01; 20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088390-001LIGNOSPAN STANDARDEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDEEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A088390-001LIGNOSPAN STANDARDEQ 0.01MG BASE/ML;2%INJECTABLE / INJECTIONRLD, RS1985-01-22a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dentalc5cc87df-df3f-42b8-af84-5f2045d420842026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein Inc.f8d90500-f797-4238-8dd2-b59cbcd89d122026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENovocol Pharmaceutical of Canada, Inc.2005680a-8a23-4403-a618-e4ee74fa11212026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
Lignospan StandardLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.f902d2b4-28fc-41b1-a9f7-0d1a63c598aa2025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESafco Dental Supply Co6721c3ab-c37f-4504-aebc-0103c56ed5672024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENDC, Inc.937e9341-e604-4ca7-98e1-fc7c659d82e92024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEThe Atlanta Dental Supply Company DBA Advanced Dental Products55030c51-250b-4fc2-ba3c-ac38dab7cc8e2024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.864e511b-cc50-4ed9-b122-8e1a934573322024-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390
ndc (package): 0362-0898-05
ndc (product): 0362-0898
ndc11 (package): 00362089805
XylocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical14b55cf9-f7cd-4bb4-a7c5-aba61abadef12024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088390
application number: ANDA088390

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.01 mg/mL
EPINEPHRINE BITARTRATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293648Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
864e511b-cc50-4ed9-b122-8e1a93457332Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0362-0898-05Lidocaine50 in 1 CARTONINJECTION, SOLUTION504
0362-0898-05Lidocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0362-0898-05ML - Milliliter0362-0898b03d0f2a-7501-46da-8f5c-13bdf567155312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0362-0898LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.]4Current NDC, Legacy NDC, 2 package rows20240209_864e511b-cc50-4ed9-b122-8e1a93457332.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293648lidocaine HCl 2 % / EPINEPHrine 1:100,000 in 1.7 mL Dental CartridgePSN864e511b-cc50-4ed9-b122-8e1a934573324
12936481.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML CartridgeSCD864e511b-cc50-4ed9-b122-8e1a934573324
1293648lidocaine HCl 2 % / epinephrine 1:100,000 1.7 ML Dental CartridgeSY864e511b-cc50-4ed9-b122-8e1a934573324
1293648lidocaine HCl 2 % with epinephrine 1:100,000 1.7 ML Dental CartridgeSY864e511b-cc50-4ed9-b122-8e1a934573324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0362-0898-050036208980550 CARTRIDGE in 1 CARTON (0362-0898-05) / 1.7 mL in 1 CARTRIDGE50 cartridge2018-07-180000-00-00NoNoCurrent