Lidocaine

Product NDC
0143-9575
Requested package NDC
0143-9575-10
11-digit product format
001439575
Labeler code
0143
Product ID
0143-9575_e9b92d4d-8944-4235-8d77-3218f82f00a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080407
Marketing category
ANDA
Marketing start
1972-02-14
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 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
A080407-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982
A080407-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A080407-001AP
A080407-002AP

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 UTC2026-02A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…

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
2026-02-19 14:30 UTC2026-02A080407-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080407-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080407-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080407-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080407-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080407-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080407-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080407-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080407-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080407-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080407-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080407-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080407-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080407-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080407-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080407-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080407-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080407-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080407-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A080407-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080407-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080407-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080407-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080407-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080407-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080407-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080407-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080407-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080407-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080407-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080407-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080407-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080407-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080407-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A080407-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080407-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080407-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A080407-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080407-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080407-002AP187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010033Internal RxNorm lookup
1010671Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5523fdfe-69fd-49a5-b51f-73e2223d49a9Available 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
0143-9575-01Lidocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION506
0143-9575-10Lidocaine10 in 1 PACKAGEINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9575-01ML - Milliliter0143-9575e0e5c666-8931-44d8-b700-5faf7af1888012017-10-13
0143-9575-10ML - Milliliter0143-957523cc4249-984a-418e-a4b5-e58307ead77412017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9575LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION LIDOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20250521_5523fdfe-69fd-49a5-b51f-73e2223d49a9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEA-S Medication Solutionse6c83ad7-2821-432b-8610-0f54cfe610cb2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst953471e2-9efb-adf0-e053-2a95a90afd952025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.5523fdfe-69fd-49a5-b51f-73e2223d49a92025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
ndc (package): 0143-9575-10
ndc (product): 0143-9575
ndc11 (package): 00143957510
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86083fea-c064-4ef7-e053-2a91aa0ac17c2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86093c75-6dde-bb16-e053-2991aa0ab6ef2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010671lidocaine HCl 2 % Injectable SolutionPSNe6c83ad7-2821-432b-8610-0f54cfe610cb9
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDe6c83ad7-2821-432b-8610-0f54cfe610cb9
1010671lidocaine hydrochloride 2 % Injectable SolutionSYe6c83ad7-2821-432b-8610-0f54cfe610cb9
1010033lidocaine HCl 1 % Injectable SolutionPSN5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine HCl 2 % Injectable SolutionPSN5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine HCl 2 % Injectable SolutionPSN953471e2-9efb-adf0-e053-2a95a90afd956
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD953471e2-9efb-adf0-e053-2a95a90afd956
1010033lidocaine hydrochloride 1 % Injectable SolutionSY5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 2 % Injectable SolutionSY5523fdfe-69fd-49a5-b51f-73e2223d49a96
1010671lidocaine hydrochloride 2 % Injectable SolutionSY953471e2-9efb-adf0-e053-2a95a90afd956
1010671lidocaine HCl 2 % Injectable SolutionPSN86083fea-c064-4ef7-e053-2a91aa0ac17c4
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD86083fea-c064-4ef7-e053-2a91aa0ac17c4
1010671lidocaine hydrochloride 2 % Injectable SolutionSY86083fea-c064-4ef7-e053-2a91aa0ac17c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9575-100014395751010 VIAL, MULTI-DOSE in 1 PACKAGE (0143-9575-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9575-01) 1972-02-140000-00-00NoNoCurrent