Lidocaine Hydrochloride

Product NDC
55150-159
11-digit product format
551500159
Labeler code
55150
Product ID
55150-159_cc439f66-fdd6-41f9-8a08-3f623898f20c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA203040
Marketing category
ANDA
Marketing start
2013-03-14
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTION2013-03-14
A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTION2013-03-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTION2013-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTION2013-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTION2013-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTION2013-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTION2013-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTION2013-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203040-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A203040-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203040-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203040-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203040-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203040-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203040-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203040-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203040-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203040-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203040-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203040-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203040-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203040-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203040-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203040-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203040-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203040-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203040-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203040-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203040-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203040-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203040-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203040-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203040-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203040-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203040-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203040-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203040-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203040-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203040-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203040-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203040-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203040-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203040-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203040-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203040-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203040-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203040-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203040-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203040-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203040-002AP18869cabd3fbd…

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737566Internal RxNorm lookup
1737568Internal RxNorm lookup
1737757Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5524cbfd-d6e6-42eb-aaa5-22495e0a86b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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
55150-159-74Lidocaine Hydrochloride5 mL in 1 AMPULEINJECTION, SOLUTION58
55150-159-74Lidocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-159-74ML - Milliliter55150-159d50f85f4-930d-4c11-ac95-d3f84d0615da12014-01-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-159LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]7Current NDC, Legacy NDC, 2 package rows20240410_5524cbfd-d6e6-42eb-aaa5-22495e0a86b6.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC5524cbfd-d6e6-42eb-aaa5-22495e0a86b62025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203040
application number: ANDA203040
ndc (product): 55150-159
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e412b4c-e24f-69ea-e053-2995a90ac6002023-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203040
application number: ANDA203040
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.8ae0656c-36fb-48fb-886b-1031d11da5522022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203040
application number: ANDA203040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737566lidocaine HCl 1 % in 5 ML InjectionPSN5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737757lidocaine HCl 2 % in 2 ML InjectionPSN5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
17377572 ML lidocaine hydrochloride 20 MG/ML InjectionSCD5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737568lidocaine HCl 1 % per 2 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737566lidocaine HCl 1 % per 5 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737757lidocaine HCl 2 % per 2 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737568lidocaine HCl 20 MG per 2 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737757lidocaine HCl 40 MG per 2 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737566lidocaine HCl 50 MG per 5 ML InjectionSY5524cbfd-d6e6-42eb-aaa5-22495e0a86b68
1737566lidocaine HCl 1 % in 5 ML InjectionPSN9e412b4c-e24f-69ea-e053-2995a90ac6002
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD9e412b4c-e24f-69ea-e053-2995a90ac6002
1737566lidocaine HCl 1 % per 5 ML InjectionSY9e412b4c-e24f-69ea-e053-2995a90ac6002
1737566lidocaine HCl 50 MG per 5 ML InjectionSY9e412b4c-e24f-69ea-e053-2995a90ac6002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-159-745515001597410 AMPULE in 1 CARTON (55150-159-74) / 5 mL in 1 AMPULE10 ampule2013-03-140000-00-00NoNoCurrent