Home NDC 51662-1596 LIDOCAINE HCl
Product NDC 51662-1596
11-digit product format 516621596
Labeler code 51662
Product ID 51662-1596_0ff8ef97-0071-e6ca-e063-6294a90a2365
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HCl
Dosage form INJECTION, SOLUTION
Route RETROBULBAR; TOPICAL; TRANSTRACHEAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA088295
Marketing category ANDA
Marketing start 2022-09-15
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 42 .
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 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP RS 1984-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088295-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 e64feba35796…
Observed Orange Book normalized TE history# 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 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 1010844 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 51662-1596-2 LIDOCAINE HCl 5 mL in 1 AMPULE INJECTION, SOLUTION 5 2 51662-1596-2 LIDOCAINE HCl 1 in 1 POUCH INJECTION, SOLUTION 1 2 51662-1596-3 LIDOCAINE HCl 25 in 1 CASE INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1596 LIDOCAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 3 package rows 20240129_e8bc96bc-7876-4906-e053-2a95a90ae6ba.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 51662-1596-2 51662159602 5 mL in 1 AMPULE 5 ml Historical 51662-1596-3 51662159603 25 POUCH in 1 CASE (51662-1596-3) / 1 AMPULE in 1 POUCH (51662-1596-2) / 5 mL in 1 AMPULE 25 pouch 2022-09-15 0000-00-00 No No Current