Lidocaine Hydrochloride

Product NDC
63739-470
Requested package NDC
63739-470-21
11-digit product format
637390470
Labeler code
63739
Product ID
63739-470_8a5eff85-fec9-4a97-8fe4-aaf32e8eee13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA088327
Marketing category
ANDA
Marketing start
2005-06-15
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage63739-47063739-470-21DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-470-212020-07-22C16284748780-1ab0e2407-294a-f274-e053-dbdaa90a6471Lidocaine Hydrochloride Injection, USP

DailyMed Socrata Ingredients#

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63739-470-21637390470215 VIAL, MULTI-DOSE in 1 BOX (63739-470-21) > 50 mL in 1 VIAL, MULTI-DOSE2005-06-150000-00-00NoNoCurrent