Home NDC 72162-2627 Lidocaine Hydrochloride
Product NDC 72162-2627
11-digit product format 721622627
Labeler code 72162
Product ID 72162-2627_6c6ea160-ea31-4d1e-9746-eef1a72dd178
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA218411
Marketing category ANDA
Marketing start 2024-11-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 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 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 A218411-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218411-001 AT
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.
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 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218411-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2024-04-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 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 1010878 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 72162-2627-2 Lidocaine Hydrochloride 50 mL in 1 BOTTLE SOLUTION 50 100 72162-2627-2 Lidocaine Hydrochloride 1 in 1 CARTON SOLUTION 1 100
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 72162-2627-2 72162262702 1 BOTTLE in 1 CARTON (72162-2627-2) / 50 mL in 1 BOTTLE 1 bottle 2026-04-23 No No Current