Home NDC 0054-3500-49 Lidocaine Viscous
Product NDC 0054-3500
Requested package NDC 0054-3500-49
11-digit product format 000543500
Labeler code 0054
Product ID 0054-3500_182f3e6b-1622-4eef-80e5-d08ffbbbd30e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form SOLUTION
Route ORAL; TOPICAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA088802
Marketing category ANDA
Marketing start 1985-04-26
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 A088802-001 LIDOCAINE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION / ORAL AT 1985-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088802-001 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.
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 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088802-001 LIDOCAINE VISCOUS 2% SOLUTION / ORAL AT 1985-04-26 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 Viscous
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 0054-3500-49 Lidocaine Viscous 1 in 1 CARTON SOLUTION 1 15 0054-3500-49 Lidocaine Viscous 100 mL in 1 BOTTLE SOLUTION 100 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3500 LIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, Legacy NDC, 2 package rows 20241219_79b42076-359d-4258-b1d8-f40e67ac5424.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Viscous LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. 6f8d20d2-6a91-4a5b-bfe8-f1baada38442 2026-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 Lidocaine Viscous LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 79b42076-359d-4258-b1d8-f40e67ac5424 2024-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 ndc (package): 0054-3500-49 ndc (product): 0054-3500 ndc11 (package): 00054350049 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 0050d05a-b8e9-c544-e063-6294a90a0243 2024-02-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802 Lidocaine Viscous LIDOCAINE HYDROCHLORIDE A-S Medication Solutions 75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088802 application number: ANDA088802
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 0054-3500-49 00054350049 1 BOTTLE in 1 CARTON (0054-3500-49) / 100 mL in 1 BOTTLE 1 bottle 1985-04-26 0000-00-00 No No Current