FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
73293-0003
Requested package NDC
73293-0003-2
11-digit product format
732930003
Labeler code
73293
Product ID
73293-0003_4711fd53-dad3-f117-e063-6394a90a8d3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Huons Co., Ltd.
Application
ANDA212821
Marketing category
ANDA
Marketing start
2023-06-15
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212821-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2020-05-07
A212821-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212821-001AP
A212821-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212821-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2020-05-07a50c72e98297…
2026-08-01 22:54:322026-06A212821-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2023-06-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212821-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A212821-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPrecision Dose, Inc.27b6ef54-a093-2bef-e063-6394a90a79122025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEBrookfield Pharmaceuticals, LLC.e824ba5b-3289-5ad4-e053-2995a90acc202025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.42531a38-7cff-de16-e063-6394a90a18d82025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHuons Co., Ltd.8ec2d256-fc4f-44f6-bee2-eef2bf3bf5802025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821
ndc (package): 73293-0003-2
ndc (product): 73293-0003
ndc11 (package): 73293000302
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovagenix Labs LLC7567ffb5-953a-4be9-9a02-c5a50dcd93062025-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMcKesson Corporation dba SKY Packaginge1eabd6b-9bb8-646f-e053-2a95a90a7b832025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212821
application number: ANDA212821

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010033Internal RxNorm lookup
1010671Internal RxNorm lookup
1737566Internal RxNorm lookup
1737761Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ec2d256-fc4f-44f6-bee2-eef2bf3bf580Available on FDA.report

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
73293-0003-1Lidocaine Hydrochloride5 mL in 1 VIALSOLUTION511
73293-0003-2Lidocaine Hydrochloride10 in 1 BOXSOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73293-0003LIDOCAINE HYDROCHLORIDE SOLUTION [HUONS CO., LTD.]10Current NDC, 2 package rows20240328_8ec2d256-fc4f-44f6-bee2-eef2bf3bf580.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737566lidocaine HCl 1 % in 5 ML InjectionPSN8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010033lidocaine HCl 1 % Injectable SolutionPSN8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1737761lidocaine HCl 2 % in 5 ML InjectionPSN8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010671lidocaine HCl 2 % Injectable SolutionPSN8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1737566lidocaine HCl 1 % per 5 ML InjectionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1737761lidocaine HCl 100 MG per 5 ML InjectionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1737761lidocaine HCl 2 % per 5 ML InjectionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1737566lidocaine HCl 50 MG per 5 ML InjectionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010033lidocaine hydrochloride 1 % Injectable SolutionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011
1010671lidocaine hydrochloride 2 % Injectable SolutionSY8ec2d256-fc4f-44f6-bee2-eef2bf3bf58011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73293-0003-27329300030210 VIAL in 1 BOX (73293-0003-2) / 5 mL in 1 VIAL (73293-0003-1) 10 vial2023-06-16NoNoCurrent