Home NDC 76420-079 Lidocaine Hydrochloride
Product NDC 76420-079
11-digit product format 764200079
Labeler code 76420
Product ID 76420-079_ead2e17d-c777-57a3-e053-2995a90af78b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler Asclemed USA, Inc.
Application ANDA203040
Marketing category ANDA
Marketing start 2013-03-14
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION 2013-03-14 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION 2013-03-14
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 3 · 82 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 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION 2013-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION 2013-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION 2013-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION 2013-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION 2013-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION 2013-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203040-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP 2013-03-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203040-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 2% INJECTABLE / INJECTION AP 2013-03-14 782e0a99824c…
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 Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 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 1737757 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 76420-079-01 Lidocaine Hydrochloride 2 mL in 1 AMPULE INJECTION, SOLUTION 2 2 76420-079-10 Lidocaine Hydrochloride 2 mL in 1 AMPULE INJECTION, SOLUTION 2 2 76420-079-10 Lidocaine Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-079 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20221013_8ae0656c-36fb-48fb-886b-1031d11da552.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 76420-079-01 76420007901 2 mL in 1 AMPULE (76420-079-01) 2 ml 2020-02-12 0000-00-00 No No Current 76420-079-10 76420007910 10 AMPULE in 1 CARTON (76420-079-10) / 2 mL in 1 AMPULE 10 ampule 2020-02-12 0000-00-00 No No Current