FDA.reportPublic FDA data

lidocaine hydrochloride

Product NDC
83634-651
Requested package NDC
83634-651-20
11-digit product format
836340651
Labeler code
83634
Product ID
83634-651_8fb1dd7b-f349-4a64-96c1-bd72bf748f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Avenacy, LLC
Application
ANDA219535
Marketing category
ANDA
Marketing start
2025-07-01
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 43.

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
A219535-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-02
A219535-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219535-001AP
A219535-002AP

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
2026-09-14 22:38:342026-08A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-0284e616aacf4f…
2026-09-14 22:38:342026-08A219535-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219535-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219535-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219535-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2025-04-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219535-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219535-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A219535-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A219535-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A219535-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219535-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219535-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219535-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219535-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219535-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219535-002AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
lidocaine hydrochloride
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010033Internal RxNorm lookup
1737562Internal RxNorm lookup
1737566Internal RxNorm lookup
1737568Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46480253-29b9-4d7f-98ed-10377929026bAvailable 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
83634-651-10lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
83634-651-20lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
83634-651-41lidocaine hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
83634-651-42lidocaine hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION204
83634-651-43lidocaine hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION504
83634-651-50lidocaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-651-50ML - Milliliter83634-65163040268-2685-47c5-8822-61d10c46d17112025-09-12

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 HYDROCHLORIDESandoz Inc.dc476ebd-fd57-41c3-a649-7185a784a39f2026-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219535
application number: ANDA219535
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAnthea Pharma Private Limited240c4744-e58c-4c08-93ad-8d6418c4f8a92026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219535
application number: ANDA219535
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAvenacy, LLC46480253-29b9-4d7f-98ed-10377929026b2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219535
application number: ANDA219535
ndc (package): 83634-651-20
ndc (product): 83634-651
ndc11 (package): 83634065120
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC4643042c-ec95-3bad-e063-6294a90a82502025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219535
application number: ANDA219535

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737568lidocaine HCl 1 % in 2 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 1 % in 30 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 1 % in 5 ML InjectionPSN46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine HCl 1 % Injectable SolutionPSN46480253-29b9-4d7f-98ed-10377929026b4
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
173756230 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD46480253-29b9-4d7f-98ed-10377929026b4
1737568lidocaine HCl 1 % per 2 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 1 % per 30 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 1 % per 5 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737568lidocaine HCl 20 MG per 2 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737562lidocaine HCl 300 MG per 30 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1737566lidocaine HCl 50 MG per 5 ML InjectionSY46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine hydrochloride 1 % Injectable SolutionSY46480253-29b9-4d7f-98ed-10377929026b4
1010033lidocaine HCl 1 % Injectable SolutionPSN4643042c-ec95-3bad-e063-6294a90a82501
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD4643042c-ec95-3bad-e063-6294a90a82501
1010033lidocaine hydrochloride 1 % Injectable SolutionSY4643042c-ec95-3bad-e063-6294a90a82501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-651-208363406512025 VIAL, MULTI-DOSE in 1 CARTON (83634-651-20) / 20 mL in 1 VIAL, MULTI-DOSE (83634-651-42) 2026-02-15NoNoCurrent