Lidocaine hydrochloride

Product NDC
80425-0268
11-digit product format
804250268
Labeler code
80425
Product ID
80425-0268_2a9b9724-0254-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA203082
Marketing category
ANDA
Marketing start
2023-02-15
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
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
A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2013-03-14
A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2013-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203082-001AP
A203082-002AP

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 UTC2026-02A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203082-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A203082-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE2%INJECTABLE / INJECTIONAP2013-03-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203082-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203082-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203082-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203082-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203082-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203082-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203082-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203082-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203082-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203082-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203082-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203082-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203082-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203082-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203082-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203082-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203082-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203082-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203082-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203082-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203082-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203082-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203082-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203082-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203082-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203082-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203082-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203082-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203082-002AP1782e0a99824c…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737562Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4c19cf5-c8b1-5e9f-e053-2995a90aee53Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0268-1Lidocaine hydrochloride1 in 1 CARTONINJECTION, SOLUTION12
80425-0268-1Lidocaine hydrochloride30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0268-1ML - Milliliter80425-02687786b5f3-ad71-4874-954d-fbe9554917ef12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0268LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f4c19cf5-c8b1-5e9f-e053-2995a90aee53.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESportpharm LLC5b74b6f4-f26f-4243-8060-cd17779079842026-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC89701fac-7536-4f16-87fb-f4cc121e74ee2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC9916b09d-a116-469d-92d5-60e50ea9782b2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4c19cf5-c8b1-5e9f-e053-2995a90aee532024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
ndc (product): 80425-0268
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1b584ef0-3663-0d2a-e063-6394a90a17572024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC79798b21-026d-1b4c-e053-2a91aa0a01292023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.55a8372e-70d6-4b70-ac95-5226d0f5812a2023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.b8803e38-fe30-48ec-9399-013f2880e0eb2020-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203082
application number: ANDA203082

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737562lidocaine HCl 1 % in 30 ML InjectionPSNf4c19cf5-c8b1-5e9f-e053-2995a90aee532
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCDf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737562lidocaine HCl 1 % per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532
1737562lidocaine HCl 300 MG per 30 ML InjectionSYf4c19cf5-c8b1-5e9f-e053-2995a90aee532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0268-1804250268011 VIAL, SINGLE-DOSE in 1 CARTON (80425-0268-1) / 30 mL in 1 VIAL, SINGLE-DOSE2023-02-15NoNoCurrent