Home NDC 63739-997-64 Lidocaine Hydrochloride
Product NDC 63739-997
Requested package NDC 63739-997-64
11-digit product format 637390997
Labeler code 63739
Product ID 63739-997_0b1800c4-84d7-4c41-acf3-5f3e8f2e2a8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler McKesson Corporation dba SKY Packaging
Application ANDA204494
Marketing category ANDA
Marketing start 2024-06-27
Marketing end 2027-03-31
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Current FDA listing Yes 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63739-997 63739-997-64 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204494-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204494-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204494-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2014-03-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010878 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63739-997-64 Lidocaine Hydrochloride 50 mL in 1 BOTTLE SOLUTION 50 9 63739-997-64 Lidocaine Hydrochloride 1 in 1 CARTON SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63739-997 LIDOCAINE HYDROCHLORIDE SOLUTION [MCKESSON CORPORATION DBA SKY PACKAGING] 9 Current NDC, Legacy NDC, 2 package rows 20241212_903cd7bd-6c3d-4068-bb24-e91b1ca1393d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63739-997-64 63739099764 1 BOTTLE in 1 CARTON (63739-997-64) / 50 mL in 1 BOTTLE 1 bottle 2024-06-27 2027-03-31 No No Current