Home NDC 83634-653 lidocaine hydrochloride
Product NDC 83634-653
11-digit product format 836340653
Labeler code 83634
Product ID 83634-653_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lidocaine hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler Avenacy, LLC
Application ANDA219535
Marketing category ANDA
Marketing start 2025-12-31
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 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 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010033 Internal RxNorm lookup 1737562 Internal RxNorm lookup 1737566 Internal RxNorm lookup 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 83634-653-02 lidocaine hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 4 83634-653-05 lidocaine hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 4 83634-653-30 lidocaine hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 4 83634-653-41 lidocaine hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 4 83634-653-42 lidocaine hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 4 83634-653-43 lidocaine hydrochloride 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 4
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 83634-653-02 83634065302 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-653-41) 2025-12-31 No No Current 83634-653-05 83634065305 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-653-42) 2025-12-31 No No Current 83634-653-30 83634065330 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-30) / 30 mL in 1 VIAL, SINGLE-DOSE (83634-653-43) 2025-12-31 No No Current 83634-653-41 83634065341 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 83634-653-42 83634065342 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 83634-653-43 83634065343 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical