Home NDC 50102-400-10 Lidocaine Hydrochloride
Product NDC 50102-400
Requested package NDC 50102-400-10
11-digit product format 501020400
Labeler code 50102
Product ID 50102-400_0d93c3cd-c678-4304-8bfd-47a9c529c6f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine hydrochloride
Dosage form INJECTION
Route INFILTRATION; PERINEURAL
Labeler Afaxys Pharma LLC
Application ANDA215132
Marketing category ANDA
Marketing start 2022-06-29
Marketing end 0000-00-00
Substance LIDOCAINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50102-400 50102-400-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50102-400 50102-400-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50102-400 50102-400-10 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 A215132-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215132-001 AP
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 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION 2022-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION 2022-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215132-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-06-09 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50102-400 LIDOCAINE HYDROCHLORIDE INJECTION [AFAXYS PHARMA LLC] 7 Legacy NDC 20250120_b54f5334-cdf1-8a22-e053-2995a90ad6da.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50102-400-10 50102040010 10 VIAL, MULTI-DOSE in 1 TRAY (50102-400-10) > 20 mL in 1 VIAL, MULTI-DOSE (50102-400-01) 2022-06-29 0000-00-00 No No Current