Home NDC 76420-084 Lidocaine Hydrochloride
Product NDC 76420-084
11-digit product format 764200084
Labeler code 76420
Product ID 76420-084_ead317e5-93f1-fd8d-e053-2995a90adbf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler Asclemed USA, Inc.
Application ANDA080408
Marketing category ANDA
Marketing start 2005-07-08
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 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 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 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 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 1737568 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 76420-084-02 Lidocaine Hydrochloride 2 mL in 1 AMPULE INJECTION, SOLUTION 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-084 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20221013_deec52c7-ebcf-422e-beab-bc1df2fe30cb.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 3b2dd84e-cee8-4e58-d494-395a65a353a0 2026-01-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Henry Schein, Inc. a5d4b206-cc53-470f-9bca-abfc6ea5cc99 2025-09-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 LIDOCAINE HCl LIDOCAINE HCL HF Acquisition Co LLC, DBA HealthFirst e39435a3-1f69-78c5-e053-2995a90a7fc3 2024-01-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Asclemed USA, Inc. deec52c7-ebcf-422e-beab-bc1df2fe30cb 2022-10-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (product): 76420-084
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 76420-084-02 76420008402 2 mL in 1 AMPULE (76420-084-02) 2 ml 2020-05-06 0000-00-00 No No Current