Home NDC 59651-591-50 Lidocaine
Product NDC 59651-591
Requested package NDC 59651-591-50
11-digit product format 596510591
Labeler code 59651
Product ID 59651-591_9312d01c-00d0-4e8b-b6b6-3aaf80e25d8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler Aurobindo Pharma Limited
Application ANDA217117
Marketing category ANDA
Marketing start 2024-06-18
Substance LIDOCAINE
Active strength 50 mg/g
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 43 .
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 A217117-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217117-001 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 2026-09-14 22:38:34 2026-08 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217117-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2024-06-18 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1543069 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 59651-591-30 Lidocaine 30 g in 1 TUBE OINTMENT 30 2 59651-591-30 Lidocaine 1 in 1 CARTON OINTMENT 1 2 59651-591-35 Lidocaine 35.44 g in 1 TUBE OINTMENT 35.44 2 59651-591-35 Lidocaine 1 in 1 CARTON OINTMENT 1 2 59651-591-50 Lidocaine 50 g in 1 JAR OINTMENT 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-591 LIDOCAINE OINTMENT [AUROBINDO PHARMA LIMITED] 2 Current NDC, 5 package rows 20240911_29199070-6dcb-4086-9a68-49e819965dbd.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 59651-591-50 59651059150 50 g in 1 JAR (59651-591-50) 50 g 2024-06-18 No No Current