Home NDC 0409-4904 Lidocaine Hydrochloride
Product NDC 0409-4904
11-digit product format 004094904
Labeler code 0409
Product ID 0409-4904_3a6e4402-7b97-4d62-8239-16c2ff17009d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA083158
Marketing category ANDA
Marketing start 2005-08-30
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0409-4904 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-4904 0409-4904-34 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083158-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION RLD, Approved before 1982 A083158-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION RLD, Approved before 1982 A083158-003 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE / INJECTION Approved before 1982 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE / INJECTION Approved before 1982
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 6 · 215 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 2026-09-14 22:38:34 2026-08 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083158-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083158-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083158-003 LIDOCAINE HYDROCHLORIDE 20% INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083158-005 LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% 200MG/100ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083158-006 LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 400MG/100ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-4904-11 Lidocaine Hydrochloride 5 mL in 1 SYRINGE INJECTION, SOLUTION 5 30 0409-4904-34 Lidocaine Hydrochloride 10 in 1 CONTAINER INJECTION, SOLUTION 10 30 0409-4904-34 Lidocaine Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 30
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 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 13 Lidocaine Hydrochloride ACTIVE INGREDIENT V13007Z41A LIDOCAINE HYDROCHLORIDE (LIDOCAINE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINE, INC] 2 Lidocaine ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE (LIDOCAINE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINE, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4904 LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 28 Legacy NDC, 3 package rows 20250417_ad1ef0a8-88db-4648-c098-d009eaeb4e5b.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 Units Marketing start Marketing end Sample Exclude flag Status 0409-4904-10 00409490410 10 CARTON in 1 CONTAINER (0409-4904-10) > 1 SYRINGE in 1 CARTON > 5 mL in 1 SYRINGE (0409-4904-05) 10 carton 2021-03-01 0000-00-00 No No Current 0409-4904-11 00409490411 5 mL in 1 SYRINGE 5 ml Historical 0409-4904-34 00409490434 10 CARTON in 1 CONTAINER (0409-4904-34) > 1 SYRINGE in 1 CARTON > 5 mL in 1 SYRINGE (0409-4904-11) 10 carton 2005-08-30 0000-00-00 No No Current