FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
10135-736
11-digit product format
101350736
Labeler code
10135
Product ID
10135-736_4260de8c-7ec7-00d0-e063-6394a90aeebd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA216250
Marketing category
ANDA
Marketing start
2022-06-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010878

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
10135-736-51Lidocaine Hydrochloride1 in 1 CARTONSOLUTION13
10135-736-51Lidocaine Hydrochloride50 mL in 1 BOTTLESOLUTION503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-736-51ML - Milliliter10135-73624847f7c-1cf8-46a1-a386-27075e91bc8912022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-736LIDOCAINE HYDROCHLORIDE SOLUTION [MARLEX PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20231116_e1badbba-59af-e451-e053-2a95a90a49f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010878lidocaine HCl 4 % Mucous Membrane Topical SolutionPSNe1badbba-59af-e451-e053-2a95a90a49f83
1010878lidocaine hydrochloride 40 MG/ML Mucous Membrane Topical SolutionSCDe1badbba-59af-e451-e053-2a95a90a49f83
1010878lidocaine hydrochloride 4 % Mucous Membrane Topical SolutionSYe1badbba-59af-e451-e053-2a95a90a49f83
1010878lidocaine hydrochloride 4 % Oromucosal SolutionSYe1badbba-59af-e451-e053-2a95a90a49f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-736-51101350736511 BOTTLE in 1 CARTON (10135-736-51) / 50 mL in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent