Home NDC 0409-4278-01 Lidocaine Hydrochloride
Product NDC 0409-4278
Requested package NDC 0409-4278-01
11-digit product format 004094278
Labeler code 0409
Product ID 0409-4278_78818553-f818-42a1-81b9-e5a5a5da5a27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INFILTRATION; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA088328
Marketing category ANDA
Marketing start 2005-06-30
Substance LIDOCAINE HYDROCHLORIDE
Active strength 5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088328-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088328-001 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 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088328-001 LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 1984-05-17 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5 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 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 0409-4278-01 Lidocaine Hydrochloride 25 in 1 TRAY INJECTION, SOLUTION 25 46 0409-4278-16 Lidocaine Hydrochloride 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 46
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE HYDROCHLORIDE ACTIVE INGREDIENT V13007Z41A LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4278 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 44 Current NDC, Legacy NDC, 2 package rows 20241206_3b2dd84e-cee8-4e58-d494-395a65a353a0.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 · 3 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 0409-4278-01 00409427801 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16) 2005-06-30 0000-00-00 No No Current