Home NDC 61919-774 LIDOCAINE
Product NDC 61919-774
11-digit product format 619190774
Labeler code 61919
Product ID 61919-774_e9ac0631-9341-ad58-e053-2a95a90a588f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE
Dosage form OINTMENT
Route TOPICAL
Labeler DIRECTRX
Application ANDA205318
Marketing category ANDA
Marketing start 2019-04-01
Marketing end 0000-00-00
Substance LIDOCAINE
Active strength 50 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-774-35 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-774-50 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-774-35 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-774-50 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-774-35 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-774-50 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-774-35 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-774-50 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-774-35 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-774-50 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-774-35 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-774-50 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-774-35 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-774-50 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-774-35 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-774-50 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-774-35 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-774-50 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A205318-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205318-001 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 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL 2016-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205318-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2016-02-01 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 61919-774-35 LIDOCAINE 35.44 g in 1 TUBE OINTMENT 35.44 3 61919-774-50 LIDOCAINE 50 g in 1 CARTON OINTMENT 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-774 LIDOCAINE OINTMENT [DIRECTRX] 3 Legacy NDC, 2 package rows 20230519_857bf526-ab2a-b173-e053-2991aa0a04cf.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 · 3 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 61919-774-35 61919077435 35.44 g in 1 TUBE (61919-774-35) 35.44 g 2019-04-01 0000-00-00 No No Current 61919-774-50 61919077450 50 g in 1 CARTON (61919-774-50) 50 g 2022-09-27 0000-00-00 No No Current