Home NDC 51662-1593-3 LIDOCAINE HCl
Product NDC 51662-1593
Requested package NDC 51662-1593-3
11-digit product format 516621593
Labeler code 51662
Product ID 51662-1593_0ff94251-015a-e1eb-e063-6394a90a59e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HCl
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA080408
Marketing category ANDA
Marketing start 2022-07-11
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP Approved before 1982 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-01 22:54:32 2026-06 A080408-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1% INJECTABLE / INJECTION AP Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 A080408-002 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 1.5% INJECTABLE / INJECTION AP Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A080408-001 AP 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A080408-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 3b2dd84e-cee8-4e58-d494-395a65a353a0 2026-01-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Henry Schein, Inc. a5d4b206-cc53-470f-9bca-abfc6ea5cc99 2025-09-29 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 LIDOCAINE HCl LIDOCAINE HCL HF Acquisition Co LLC, DBA HealthFirst e39435a3-1f69-78c5-e053-2995a90a7fc3 2024-01-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408 ndc (package): 51662-1593-3 ndc (product): 51662-1593 ndc11 (package): 51662159303 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Asclemed USA, Inc. deec52c7-ebcf-422e-beab-bc1df2fe30cb 2022-10-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 080408 application number: ANDA080408
Additional Listing Data#
Finished product Yes
Brand name base LIDOCAINE HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 10 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 1737568 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 51662-1593-2 LIDOCAINE HCl 1 in 1 POUCH INJECTION, SOLUTION 1 2 51662-1593-2 LIDOCAINE HCl 2 mL in 1 AMPULE INJECTION, SOLUTION 2 2 51662-1593-3 LIDOCAINE HCl 50 in 1 CASE INJECTION, SOLUTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1593 LIDOCAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 3 package rows 20240129_e39435a3-1f69-78c5-e053-2995a90a7fc3.zip
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 51662-1593-3 51662159303 50 POUCH in 1 CASE (51662-1593-3) / 1 AMPULE in 1 POUCH (51662-1593-2) / 2 mL in 1 AMPULE 50 pouch 2022-07-11 0000-00-00 No No Current