Home NDC 83148-043 Lidocaine Hydrochloride
Product NDC 83148-043
11-digit product format 831480043
Labeler code 83148
Product ID 83148-043_407bbf7a-4ffe-b9ec-e063-6394a90a76bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route TOPICAL
Labeler The J. Molner Company LLC
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 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 · 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83148-043-50 Lidocaine Hydrochloride 50 mL in 1 BOTTLE SOLUTION 50 5 83148-043-50 Lidocaine Hydrochloride 1 in 1 CARTON SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83148-043 LIDOCAINE HYDROCHLORIDE SOLUTION [THE J. MOLNER COMPANY LLC] 4 Current NDC, 2 package rows 20241115_17880468-873f-6465-e063-6294a90a9c73.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 · 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 83148-043-50 83148004350 1 BOTTLE in 1 CARTON (83148-043-50) / 50 mL in 1 BOTTLE 1 bottle 2024-11-01 No No Current