LIDOCAINE HYDROCHLORIDE

Product NDC
59651-943
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

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 Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010739

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

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