FDA.reportPublic FDA data

LIDOCAINE HYDROCHLORIDE

Product NDC
59651-943
Requested package NDC
59651-943-01
11-digit product format
596510943
Labeler code
59651
Product ID
59651-943_ab461805-413a-4fb3-88a1-224e1c423084
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219759
Marketing category
ANDA
Marketing start
2025-07-29
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219759-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2025-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219759-001AT

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
2026-02-19 14:30 UTC2026-02A219759-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2025-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219759-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2025-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A219759-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2025-07-296a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219759-001LIDOCAINE HYDROCHLORIDE2%SOLUTION / ORALAT2025-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219759-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219759-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219759-001AT16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219759-001AT1a50c72e98297…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010739Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab461805-413a-4fb3-88a1-224e1c423084Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-943-01LIDOCAINE HYDROCHLORIDE100 mL in 1 BOTTLESOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-943-01ML - Milliliter59651-943186dafac-f324-4351-bd8a-9cfbeb5fb59e12026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEAurobindo Pharma Limitedab461805-413a-4fb3-88a1-224e1c4230842025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219759
application number: ANDA219759
ndc (package): 59651-943-01
ndc (product): 59651-943
ndc11 (package): 59651094301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSNab461805-413a-4fb3-88a1-224e1c4230841
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCDab461805-413a-4fb3-88a1-224e1c4230841
1010739lidocaine HCl 2 % Oral Topical SolutionSYab461805-413a-4fb3-88a1-224e1c4230841
1010739lidocaine HCl 2 % Oromucosal SolutionSYab461805-413a-4fb3-88a1-224e1c4230841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-943-0159651094301100 mL in 1 BOTTLE (59651-943-01) 100 ml2025-07-29NoNoCurrent