Home NDC 0404-9886-50 Lidocaine Hydrochloride and Epinephrine
Product NDC 0404-9886
Requested package NDC 0404-9886-50
11-digit product format 004049886
Labeler code 0404
Product ID 0404-9886_b44c0782-afe0-4a33-b000-ca8807a79a40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride and Epinephrine
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Henry Schein, Inc.
Application ANDA089635
Marketing category ANDA
Marketing start 2022-01-11
Substance EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Active strength 5; 5 ug/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089635-001 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 · 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 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089635-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;0.5% INJECTABLE / INJECTION AP 1988-06-21 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 Hydrochloride and Epinephrine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5 ug/mL EPINEPHRINE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup YKH834O4BH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010745 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 0404-9886-50 Lidocaine Hydrochloride and Epinephrine 1 in 1 BAG INJECTION, SOLUTION 1 9 0404-9886-50 Lidocaine Hydrochloride and Epinephrine 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9886 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250406_5569d607-f1cb-4f1d-8a00-d50433ec05d3.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 Marketing start Marketing end Sample Exclude flag Status 0404-9886-50 00404988650 1 VIAL, MULTI-DOSE in 1 BAG (0404-9886-50) / 50 mL in 1 VIAL, MULTI-DOSE 2022-01-11 0000-00-00 No No Current