Home NDC 52584-282-02 Lidocaine Hydrochloride
Product NDC 52584-282
Requested package NDC 52584-282-02
11-digit product format 525840282
Labeler code 52584
Product ID 52584-282_7c0d8dd7-da72-474b-b1e0-df5e25e75c79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION
Labeler General Injectables & Vaccines
Application ANDA088294
Marketing category ANDA
Marketing start 2010-04-01
Marketing end 2023-02-01
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 0000-00-00
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 44 .
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 A088294-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088294-001 AP
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 · 44 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 2026-10-15 13:18:30 2026-09 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088294-001 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1984-05-17 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# 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 52584-282-02 52584028202 1 AMPULE in 1 BAG (52584-282-02) > 10 mL in 1 AMPULE 1 ampule 2010-04-01 2023-02-01 No No Current