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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-4904DDiscontinued by firm2026-08-03
excluded packagepackage0409-49040409-4904-34DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0409-4904DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-49040409-4904-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083158-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONRLD, Approved before 1982
A083158-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONRLD, Approved before 1982
A083158-003LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982
A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%LIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONApproved before 1982
A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%LIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTIONApproved 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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-003LIDOCAINE HYDROCHLORIDE20%INJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-005LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%200MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-006LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%400MG/100MLINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083158-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A083158-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083158-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083158-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083158-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083158-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083158-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083158-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083158-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083158-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083158-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A083158-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083158-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083158-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083158-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083158-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083158-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083158-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083158-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A083158-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083158-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083158-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083158-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A083158-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083158-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A083158-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083158-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083158-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083158-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A083158-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083158-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A083158-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083158-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083158-002AP187673890dc5c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4904-11Lidocaine Hydrochloride5 mL in 1 SYRINGEINJECTION, SOLUTION530
0409-4904-34Lidocaine Hydrochloride10 in 1 CONTAINERINJECTION, SOLUTION1030
0409-4904-34Lidocaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4904-11ML - Milliliter0409-49045758e142-4b20-44d8-87c0-dcdaa11e2bbd12020-02-13
0409-4904-34ML - Milliliter0409-49043e3ecfaa-ce4c-4a8c-a63d-90a24632fd8f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4904LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]28Legacy NDC, 3 package rows20250417_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ad1ef0a8-88db-4648-c098-d009eaeb4e5b2026-06-09Warnings, Adverse reactionsExact identifier
ndc (product): 0409-4904
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co. LLC, DBA Health First74450548-62f4-b77f-e053-2991aa0ae5cf2024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co. LLC, DBA Health First7445cb32-208b-cbf7-e053-2a91aa0ad4292024-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083158
application number: ANDA083158

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012066lidocaine HCl 1 % in 5 ML Prefilled SyringePSNad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSNad1ef0a8-88db-4648-c098-d009eaeb4e5b30
10120665 ML lidocaine hydrochloride 10 MG/ML Prefilled SyringeSCDad1ef0a8-88db-4648-c098-d009eaeb4e5b30
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCDad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012066lidocaine HCl 1 % per 5 ML Prefilled SyringeSYad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012068lidocaine HCl 100 MG per 5 ML Prefilled SyringeSYad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012068lidocaine HCl 2 % per 5 ML Prefilled SyringeSYad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012066lidocaine HCl 50 MG per 5 ML Prefilled SyringeSYad1ef0a8-88db-4648-c098-d009eaeb4e5b30
1012066lidocaine HCl 1 % in 5 ML Prefilled SyringePSN7445cb32-208b-cbf7-e053-2a91aa0ad4295
10120665 ML lidocaine hydrochloride 10 MG/ML Prefilled SyringeSCD7445cb32-208b-cbf7-e053-2a91aa0ad4295
1012066lidocaine HCl 1 % per 5 ML Prefilled SyringeSY7445cb32-208b-cbf7-e053-2a91aa0ad4295
1012066lidocaine HCl 50 MG per 5 ML Prefilled SyringeSY7445cb32-208b-cbf7-e053-2a91aa0ad4295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4904-100040949041010 CARTON in 1 CONTAINER (0409-4904-10) > 1 SYRINGE in 1 CARTON > 5 mL in 1 SYRINGE (0409-4904-05) 10 carton2021-03-010000-00-00NoNoCurrent
0409-4904-11004094904115 mL in 1 SYRINGE5 mlHistorical
0409-4904-340040949043410 CARTON in 1 CONTAINER (0409-4904-34) > 1 SYRINGE in 1 CARTON > 5 mL in 1 SYRINGE (0409-4904-11) 10 carton2005-08-300000-00-00NoNoCurrent