FDA.reportPublic FDA data

0.5% LIDOCAINE HCl

Product NDC
51662-1600
Requested package NDC
51662-1600-3
11-digit product format
516621600
Labeler code
51662
Product ID
51662-1600_0ffa3920-388b-e4a5-e063-6294a90a01b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
0.5% LIDOCAINE HCl
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA088328
Marketing category
ANDA
Marketing start
2022-08-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088328-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP1984-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088328-001AP

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 22:54:322026-06A088328-001LIDOCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP1984-05-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088328-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088328
application number: ANDA088328
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ee21518e-b3ed-405a-ac3b-bfe753893dba2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088328
application number: ANDA088328
0.5% LIDOCAINE HCl0.5% LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste52fe254-8872-35ce-e053-2a95a90a339e2024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088328
application number: ANDA088328
ndc (package): 51662-1600-3
ndc (product): 51662-1600
ndc11 (package): 51662160003

Additional Listing Data#

Finished product
Yes
Brand name base
0.5% LIDOCAINE HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 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
1737343Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e52fe254-8872-35ce-e053-2a95a90a339eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1600-20.5% LIDOCAINE HCl50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION502
51662-1600-20.5% LIDOCAINE HCl1 in 1 POUCHINJECTION, SOLUTION12
51662-1600-30.5% LIDOCAINE HCl25 in 1 CASEINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-16000.5% LIDOCAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240129_e52fe254-8872-35ce-e053-2a95a90a339e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737343lidocaine HCl 0.5 % in 50 ML InjectionPSNe52fe254-8872-35ce-e053-2a95a90a339e2
173734350 ML lidocaine hydrochloride 5 MG/ML InjectionSCDe52fe254-8872-35ce-e053-2a95a90a339e2
1737343lidocaine HCl 0.5 % per 50 ML InjectionSYe52fe254-8872-35ce-e053-2a95a90a339e2
1737343lidocaine HCl 250 MG per 50 ML InjectionSYe52fe254-8872-35ce-e053-2a95a90a339e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1600-35166216000325 POUCH in 1 CASE (51662-1600-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1600-2) / 50 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-08-010000-00-00NoNoCurrent