Lidocaine Hydrochloride

Product NDC
0404-9895
11-digit product format
004049895
Labeler code
0404
Product ID
0404-9895_1012df0d-902e-468d-b1f9-a2ae4a672de2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride Anhydrous
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Henry Schein, Inc.
Application
ANDA088327
Marketing category
ANDA
Marketing start
2022-01-12
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0404-98950404-9895-50DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0404-98950404-9895-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP1984-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088327-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A088327-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001AP1cb3db0bc1861…

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
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
bb53bb10-bb36-4c9b-b632-71455615f9f3Available 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
0404-9895-20Lidocaine Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION207
0404-9895-20Lidocaine Hydrochloride1 in 1 BAGINJECTION, SOLUTION17
0404-9895-50Lidocaine Hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION507
0404-9895-50Lidocaine Hydrochloride1 in 1 BAGINJECTION, SOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9895LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [HENRY SCHEIN, INC.]6Current NDC, Legacy NDC, 4 package rows20241109_bb53bb10-bb36-4c9b-b632-71455615f9f3.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.bb53bb10-bb36-4c9b-b632-71455615f9f32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 0404-9895
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999b1c7b-3495-926a-e053-2a95a90ab2062025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC8968c61e-2686-0fe6-e053-2a95a90a15fa2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC858f3faa-e56e-51f9-e053-2a91aa0aa7212023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010671lidocaine HCl 2 % Injectable SolutionPSNbb53bb10-bb36-4c9b-b632-71455615f9f37
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCDbb53bb10-bb36-4c9b-b632-71455615f9f37
1010671lidocaine hydrochloride 2 % Injectable SolutionSYbb53bb10-bb36-4c9b-b632-71455615f9f37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9895-20004049895201 VIAL, MULTI-DOSE in 1 BAG (0404-9895-20) / 20 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent
0404-9895-50004049895501 VIAL, MULTI-DOSE in 1 BAG (0404-9895-50) > 50 mL in 1 VIAL, MULTI-DOSE2022-01-120000-00-00NoNoCurrent