Home NDC 68788-9799-1 Lidocaine Hydrochloride
Product NDC 68788-9799
Requested package NDC 68788-9799-1
11-digit product format 687889799
Labeler code 68788
Product ID 68788-9799_59a374f1-0ad6-4707-b140-adb20f6550d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route ORAL; TOPICAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA040014
Marketing category ANDA
Marketing start 2012-04-30
Marketing end 0000-00-00
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 · 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 A040014-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10
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 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1995-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1995-07-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1995-07-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1995-07-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL 1995-07-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040014-001 LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT RS 1995-07-10 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT EC2CNF7XFP LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 2
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 68788-9799-1 68788979901 100 mL in 1 BOTTLE, PLASTIC (68788-9799-1) 100 ml 2012-04-30 0000-00-00 No No Current