2% LIDOCAINE HCI

Product NDC
51662-1231
11-digit product format
516621231
Labeler code
51662
Product ID
51662-1231_132cd630-c24a-448d-e063-6294a90a33f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
2% LIDOCAINE HCI
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co. LLC, DBA Health First
Application
ANDA083158
Marketing category
ANDA
Marketing start
2018-08-25
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
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083158-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONRLD, Approved before 1982
A083158-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONRLD, Approved before 1982
A083158-003LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982
A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%LIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONApproved before 1982
A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%LIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTIONApproved before 1982

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A083158-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083158-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083158-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083158-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A083158-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083158-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083158-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083158-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083158-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083158-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083158-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083158-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A083158-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083158-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083158-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083158-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A083158-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083158-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A083158-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083158-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083158-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083158-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A083158-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083158-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A083158-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083158-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083158-002AP187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
2% LIDOCAINE HCI
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012068Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74450548-62f4-b77f-e053-2991aa0ae5cfAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1231-12020-02-07C16284748780-19d75b9d0-bad3-f424-e053-dadaa90a57ce2% LIDOCAINE HCI INJ., USP 100mg/5mL SYR
51662-1231-12020-01-31C16284748780-19d75b9d0-bad3-f424-e053-dadaa90a57ce2% LIDOCAINE HCI INJ., USP 100mg/5mL SYR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1231-12% LIDOCAINE HCI5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION57
51662-1231-12% LIDOCAINE HCI1 in 1 CARTONINJECTION, SOLUTION17
51662-1231-22% LIDOCAINE HCI1 in 1 CARTONINJECTION, SOLUTION17
51662-1231-22% LIDOCAINE HCI1 in 1 POUCHINJECTION, SOLUTION17
51662-1231-32% LIDOCAINE HCI10 in 1 CASEINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-12312% LIDOCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTH FIRST]7Current NDC, Legacy NDC, 5 package rows20240310_74450548-62f4-b77f-e053-2991aa0ae5cf.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 HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co. LLC, DBA Health First74450548-62f4-b77f-e053-2991aa0ae5cf2024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158
ndc (product): 51662-1231
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co. LLC, DBA Health First7445cb32-208b-cbf7-e053-2a91aa0ad4292024-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSN74450548-62f4-b77f-e053-2991aa0ae5cf7
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCD74450548-62f4-b77f-e053-2991aa0ae5cf7
1012068lidocaine HCl 100 MG per 5 ML Prefilled SyringeSY74450548-62f4-b77f-e053-2991aa0ae5cf7
1012068lidocaine HCl 2 % per 5 ML Prefilled SyringeSY74450548-62f4-b77f-e053-2991aa0ae5cf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1231-1516621231011 SYRINGE, PLASTIC in 1 CARTON (51662-1231-1) / 5 mL in 1 SYRINGE, PLASTIC2018-08-250000-00-00NoNoCurrent
51662-1231-2516621231021 in 1 CARTONHistorical
51662-1231-35166212310310 POUCH in 1 CASE (51662-1231-3) / 1 CARTON in 1 POUCH (51662-1231-2) / 1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE10 pouch2023-03-24NoNoCurrent