Home NDC 65282-1605 Lidocaine Hydrochloride
Product NDC 65282-1605
11-digit product format 652821605
Labeler code 65282
Product ID 65282-1605_447bfde4-fff3-32a6-e063-6394a90a667e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE ANHYDROUS
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler Spectra Medical Devices, LLC
Application ANDA208017
Marketing category ANDA
Marketing start 2018-04-18
Substance LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 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 A208017-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208017-001 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.
Product history page 1 of 2 · 41 observed 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 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208017-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2018-04-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 ANHYDROUS 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EC2CNF7XFP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737566 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 65282-1605-1 Lidocaine Hydrochloride 5 mL in 1 AMPULE INJECTION, SOLUTION 5 17 65282-1605-1 Lidocaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65282-1605 LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS) INJECTION, SOLUTION [SPECTRA MEDICAL DEVICES, LLC] 16 Current NDC, Legacy NDC, 2 package rows 20240113_e8ba012a-08a9-4f67-9f88-3284377e80be.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 Marketing end Sample Exclude flag Status 65282-1605-1 65282160501 25 AMPULE in 1 CARTON (65282-1605-1) / 5 mL in 1 AMPULE 25 ampule 2018-04-18 0000-00-00 No No Current