Home NDC 85766-063 Lidocaine
Product NDC 85766-063
11-digit product format 857660063
Labeler code 85766
Product ID 85766-063_502f1151-93e9-a77c-e063-6394a90a4425
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Sportpharm LLC
Application ANDA088586
Marketing category ANDA
Marketing start 2010-05-27
Substance LIDOCAINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 1985-07-24 A088586-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 A088586-003 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 74 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 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088586-002 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088586-003 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088586-001 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER 1% INJECTABLE / INJECTION AP 1985-07-24 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010033 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85766-063-01 Lidocaine 10 mL in 1 VIAL INJECTION, SOLUTION 10 2 85766-063-25 Lidocaine 25 in 1 TRAY INJECTION, SOLUTION 25 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-063-01 85766006301 10 mL in 1 VIAL 10 ml Historical 85766-063-25 85766006325 25 VIAL in 1 TRAY (85766-063-25) / 10 mL in 1 VIAL (85766-063-01) 25 vial 2025-09-17 No No Current