Home NDC 83854-010-27 Lidocaine Hydrochloride
Product NDC 83854-010
Requested package NDC 83854-010-27
11-digit product format 838540010
Labeler code 83854
Product ID 83854-010_4a996c97-9beb-712a-e063-6294a90a1994
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION
Labeler Anthea Pharma Private Limited
Application ANDA219535
Marketing category ANDA
Marketing start 2025-04-09
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 2027-12-31
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 A219535-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2025-04-02 A219535-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2026-02-06
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 2026-02-19 14:30 UTC 2026-02 A219535-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2025-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219535-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2026-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219535-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2025-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219535-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2025-04-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219535-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2025-04-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219535-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2026-02-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride
Listing expiration 2027-12-31 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010033 Internal RxNorm lookup 1010671 Internal RxNorm lookup 1737562 Internal RxNorm lookup 1737566 Internal RxNorm lookup 1737568 Internal RxNorm lookup 1737757 Internal RxNorm lookup 1737761 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 83854-010-01 Lidocaine Hydrochloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 20 83854-010-02 Lidocaine Hydrochloride 20 mL in 1 VIAL INJECTION, SOLUTION 20 20 83854-010-03 Lidocaine Hydrochloride 50 mL in 1 VIAL INJECTION, SOLUTION 50 20 83854-010-25 Lidocaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 20 83854-010-26 Lidocaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 20 83854-010-27 Lidocaine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 20
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83854-010-27 83854001027 25 VIAL in 1 CARTON (83854-010-27) / 50 mL in 1 VIAL (83854-010-03) 25 vial 2026-02-06 No No Current