Home NDC 51672-1411-3 Lidocaine Hydrochloride
Product NDC 51672-1411
Requested package NDC 51672-1411-3
11-digit product format 516721411
Labeler code 51672
Product ID 51672-1411_39623a94-8b8c-17c6-e063-6294a90a4c31
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA218182
Marketing category ANDA
Marketing start 2023-12-08
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 2026-12-31
Current FDA listing Yes 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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A218182-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218182-001 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 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218182-001 LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL AT 2023-12-07 a50c72e98297…
Observed Orange Book normalized TE history# 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1411-3 Lidocaine Hydrochloride 1 in 1 CARTON SOLUTION 1 5 51672-1411-3 Lidocaine Hydrochloride 50 mL in 1 BOTTLE SOLUTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1411 LIDOCAINE HYDROCHLORIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 4 Current NDC, 2 package rows 20250321_845b96c1-36a3-431f-8316-112ae881d934.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 · 1 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 51672-1411-3 51672141103 1 BOTTLE in 1 CARTON (51672-1411-3) / 50 mL in 1 BOTTLE 1 bottle 2023-12-08 No No Current