FDA.reportPublic FDA data

Lidocaine

Product NDC
85766-201
11-digit product format
857660201
Labeler code
85766
Product ID
85766-201_4ff47d39-8dff-e69b-e063-6294a90ad306
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Sportpharm LLC
Application
ANDA080407
Marketing category
ANDA
Marketing start
1972-02-14
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080407-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982
A080407-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080407-001AP
A080407-002AP

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 22:54:322026-06A080407-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A080407-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080407-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A080407-002AP1a50c72e98297…

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
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
ndc (product): 85766-201
LidocaineLIDOCAINE HYDROCHLORIDEA-S Medication Solutionse6c83ad7-2821-432b-8610-0f54cfe610cb2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst953471e2-9efb-adf0-e053-2a95a90afd952025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.5523fdfe-69fd-49a5-b51f-73e2223d49a92025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86083fea-c064-4ef7-e053-2a91aa0ac17c2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407
LidocaineLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC86093c75-6dde-bb16-e053-2991aa0ab6ef2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080407
application number: ANDA080407

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE10 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7adb9ab0-ef91-4c51-baa3-a0b7e12df077Available 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
85766-201-50Lidocaine50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010033lidocaine HCl 1 % Injectable SolutionPSN7adb9ab0-ef91-4c51-baa3-a0b7e12df0771
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD7adb9ab0-ef91-4c51-baa3-a0b7e12df0771
1010033lidocaine hydrochloride 1 % Injectable SolutionSY7adb9ab0-ef91-4c51-baa3-a0b7e12df0771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
85766-201-508576602015050 mL in 1 VIAL, MULTI-DOSE50 mlHistorical