Home NDC 0409-3177 Lidocaine Hydrochloride and Epinephrine
Product NDC 0409-3177
11-digit product format 004093177
Labeler code 0409
Product ID 0409-3177_c8636a3b-5a45-4584-a9ea-85f506901337
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE and EPINEPHRINE
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Hospira, Inc.
Application ANDA089635
Marketing category ANDA
Marketing start 2005-11-01
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 YKH834O4BH Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010688 Internal RxNorm lookup 1010745 Internal RxNorm lookup 1010751 Internal RxNorm lookup 1010759 Internal RxNorm lookup 1867996 Internal RxNorm lookup 1867998 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 0409-3177-01 Lidocaine Hydrochloride and Epinephrine 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-3177-16 Lidocaine Hydrochloride and Epinephrine 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EPINEPHRINE ACTIVE INGREDIENT YKH834O4BH LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 LIDOCAINE HYDROCHLORIDE ACTIVE INGREDIENT V13007Z41A LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 EPINEPHRINE ACTIVE MOIETY YKH834O4BH LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 13 Epinephrine ACTIVE INGREDIENT YKH834O4BH LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION [GENERAL INJECTABLES & VACCINES, INC] 1 Lidocaine Hydrochloride Anhydrous ACTIVE INGREDIENT EC2CNF7XFP LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION [GENERAL INJECTABLES & VACCINES, INC] 1 Epinephrine ACTIVE MOIETY YKH834O4BH LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION [GENERAL INJECTABLES & VACCINES, INC] 1 Lidocaine ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION [GENERAL INJECTABLES & VACCINES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-3177 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HOSPIRA, INC.] 32 Current NDC, Legacy NDC, 2 package rows 20250510_2f94f711-14c4-48ec-c5a3-c5ec4b8e8729.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1010745 lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010751 lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867996 lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 30 ML Injection PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867998 lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML Injection PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010759 lidocaine HCl 2 % / EPINEPHrine 1:100,000 Injectable Solution PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010688 lidocaine HCl 2 % / EPINEPHrine 1:200,000 in 20 ML Injection PSN 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010688 20 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 20 MG/ML Injection SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867996 30 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867998 5 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML Injection SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010745 epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010751 epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010759 epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Injectable Solution SCD 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010751 epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010759 epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 2 % Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010745 epinephrine (as epinephrine bitartrate) 1:200,000 / lidocaine hydrochloride 0.5 % Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010759 epinephrine 1:100,000 / lidocaine hydrochloride 2 % Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010745 lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010751 lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable Solution SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867996 lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 30 ML Injection SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1867998 lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML Injection SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010688 lidocaine HCl 2 % / EPINEPHrine 1:200,000 per 20 ML Injection SY 2f94f711-14c4-48ec-c5a3-c5ec4b8e8729 34 1010745 lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution PSN 5569d607-f1cb-4f1d-8a00-d50433ec05d3 9 1010745 epinephrine 0.005 MG/ML / lidocaine hydrochloride 5 MG/ML Injectable Solution SCD 5569d607-f1cb-4f1d-8a00-d50433ec05d3 9 1010745 epinephrine (as epinephrine bitartrate) 1:200,000 / lidocaine hydrochloride 0.5 % Injectable Solution SY 5569d607-f1cb-4f1d-8a00-d50433ec05d3 9 1010745 lidocaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution SY 5569d607-f1cb-4f1d-8a00-d50433ec05d3 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-3177-01 00409317701 25 VIAL, MULTI-DOSE in 1 TRAY (0409-3177-01) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3177-16) 2005-11-01 0000-00-00 No No Current 0409-3177-16 00409317716 50 mL in 1 VIAL, MULTI-DOSE 50 ml Historical