Home NDC 17478-840-05 Lidocaine
Product NDC 17478-840
Requested package NDC 17478-840-05
11-digit product format 174780840
Labeler code 17478
Product ID 17478-840_88a310c7-1020-41de-9815-fab3035e6e17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form JELLY
Route TOPICAL
Labeler Akorn, Inc.
Application ANDA040433
Marketing category ANDA
Marketing start 2013-08-01
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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 A040433-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040433-001 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 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-840 SX1 MEDICATED POST-OPERATIVE SYSTEM (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC] 4 Legacy NDC 20220302_906c715a-c47c-47f7-9ba0-4e990fb82e89.zip 17478-840 VENIPUNCTURE PX1 (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC] 4 Legacy NDC 20220302_a76e1cee-f89e-481e-adcc-0a4e3414a8be.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE HYDROCHLORIDE ARMAS PHARMACEUTICALS INC. 2f6e0f3d-ceaf-a853-e063-6394a90a8efb 2025-03-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040433 application number: ANDA040433
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 17478-840-05 17478084005 1 TUBE in 1 CARTON (17478-840-05) > 5 mL in 1 TUBE 1 tube 2013-08-01 0000-00-00 No No Current