Home NDC 0409-4283-15 Lidocaine Hydrochloride
Product NDC 0409-4283
Requested package NDC 0409-4283-15
11-digit product format 004094283
Labeler code 0409
Product ID 0409-4283_a71b2924-e8ed-489e-9e31-017dc9c7f075
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route RETROBULBAR; TOPICAL
Labeler Hospira, Inc.
Application ANDA088295
Marketing category ANDA
Marketing start 2005-06-09
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 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 45 .
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 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP RS 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 A088295-001 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 · 45 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 2026-11-14 07:37:17 2026-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION RS 1984-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088295-001 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 4% INJECTABLE / INJECTION AP RS 1984-05-17 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010844 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 0409-4283-01 Lidocaine Hydrochloride 5 in 1 PACKAGE INJECTION, SOLUTION 5 24 0409-4283-11 Lidocaine Hydrochloride 5 mL in 1 AMPULE INJECTION, SOLUTION 5 24 0409-4283-25 Lidocaine Hydrochloride 5 in 1 CELLO PACK INJECTION, SOLUTION 5 24 0409-4283-01 ENT Kit 5 mL in 1 AMPULE INJECTION, SOLUTION 5 mL 40 mg in 1mL 1
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.] 12 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 LIDOCAINE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT EC2CNF7XFP ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1 Water INACTIVE INGREDIENT 059QF0KO0R ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4283 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 23 Current NDC, Legacy NDC, 3 package rows 20241129_89a4bd73-89f4-4fd7-2c9f-921e1da8f96b.zip 0409-4283 ENT KIT () KIT [CENTURION MEDICAL PRODUCTS] 1 Current NDC, Legacy NDC 20131112_cedf83c9-dd60-4d2e-871a-e6c0b8b9fafe.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LIDOCAINE HCl LIDOCAINE HCL HF Acquisition Co LLC, DBA HealthFirst e8bc96bc-7876-4906-e053-2a95a90ae6ba 2024-01-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088295 application number: ANDA088295
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0409-4283-15 00409428315 5 CELLO PACK in 1 CARTON (0409-4283-15) / 5 AMPULE in 1 CELLO PACK (0409-4283-10) / 5 mL in 1 AMPULE (0409-4283-05) 5 cello pack 2026-10-19 No No Current