Lidocaine Hydrochloride

Product NDC
71872-7161
11-digit product format
718727161
Labeler code
71872
Product ID
71872-7161_fbc03cc2-e48a-cf45-e053-6394a90a44b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA084625
Marketing category
ANDA
Marketing start
1975-06-16
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982
A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE 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
A084625-001AP
A084625-002AP

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 UTC2026-02A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084625-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A084625-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%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 UTC2026-02A084625-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A084625-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084625-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084625-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084625-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A084625-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084625-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084625-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084625-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084625-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084625-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084625-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084625-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084625-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084625-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084625-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084625-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084625-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084625-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A084625-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084625-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084625-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084625-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084625-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084625-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084625-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084625-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A084625-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084625-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084625-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084625-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A084625-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084625-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A084625-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A084625-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A084625-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084625-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A084625-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084625-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084625-002AP187673890dc5c…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECivica, Inc.3c3b3888-fad3-440b-b627-6f79a2f4668f2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084625
application number: ANDA084625
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e12026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084625
application number: ANDA084625
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst995e68a7-6986-423e-e053-2995a90acd982024-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084625
application number: ANDA084625
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC89691444-7bfb-3314-e053-2a95a90a268e2023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084625
application number: ANDA084625
ndc (product): 71872-7161
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.fecd1797-7757-4da8-b3a1-24b2586342432022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084625
application number: ANDA084625

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
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
1737761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89691444-7bfb-3314-e053-2a95a90a268eAvailable 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
71872-7161-1Lidocaine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52
71872-7161-1Lidocaine Hydrochloride1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7161LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230516_89691444-7bfb-3314-e053-2a95a90a268e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737761lidocaine HCl 2 % in 5 ML InjectionPSN89691444-7bfb-3314-e053-2a95a90a268e2
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD89691444-7bfb-3314-e053-2a95a90a268e2
1737761lidocaine HCl 100 MG per 5 ML InjectionSY89691444-7bfb-3314-e053-2a95a90a268e2
1737761lidocaine HCl 2 % per 5 ML InjectionSY89691444-7bfb-3314-e053-2a95a90a268e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7161-1718727161011 VIAL, SINGLE-DOSE in 1 BAG (71872-7161-1) / 5 mL in 1 VIAL, SINGLE-DOSE2019-04-110000-00-00NoNoCurrent