Home NDC 68788-7999-1 LIDOCAINE HYDROCHLORIDE
Product NDC 68788-7999
Requested package NDC 68788-7999-1
11-digit product format 687887999
Labeler code 68788
Product ID 68788-7999_45eaf288-6e49-46a4-9f93-1beb5c9a2708
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA087872
Marketing category ANDA
Marketing start 2021-08-06
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 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 · 2 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-7999 68788-7999-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-7999 68788-7999-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A087872-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087872-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087872-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1982-11-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7999 LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.] 4 Legacy NDC 20240621_5936d204-e171-4389-a207-718c02e5910c.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7999-1 68788799901 100 mL in 1 BOTTLE, PLASTIC (68788-7999-1) 100 ml 2021-08-06 0000-00-00 No No Current