Home NDC 0121-4950 Lidocaine Hydrochloride
Product NDC 0121-4950
11-digit product format 001214950
Labeler code 0121
Product ID 0121-4950_8bd8bb07-066a-4c8c-ac5b-76f746318a49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA218138
Marketing category ANDA
Marketing start 2024-02-20
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 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 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 2024-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218138-001 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 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218138-001 LIDOCAINE HYDROCHLORIDE VISCOUS 2% SOLUTION / ORAL AT 2024-02-20 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 20 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 1010739 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 0121-4950-15 Lidocaine Hydrochloride 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 13 0121-4950-40 Lidocaine Hydrochloride 4 in 1 CASE SOLUTION 4 13 0121-4950-40 Lidocaine Hydrochloride 10 in 1 TRAY SOLUTION 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-4950 LIDOCAINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 13 Current NDC, 3 package rows 20250507_d5e23ede-957c-4a32-b1c6-268acb773c31.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 0121-4950-15 00121495015 15 mL in 1 CUP, UNIT-DOSE 15 ml Historical 0121-4950-40 00121495040 4 TRAY in 1 CASE (0121-4950-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4950-15) 4 tray 2024-02-20 No No Current