Lidocaine hydrochloride

Product NDC
68788-8507
11-digit product format
687888507
Labeler code
68788
Product ID
68788-8507_17d390f5-7e0d-4c3b-b86d-9cd34a67346b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216780
Marketing category
ANDA
Marketing start
2023-08-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine hydrochloride
Listing expiration
2027-12-31

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
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
68788-8507-1Lidocaine hydrochloride100 mL in 1 BOTTLESOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8507-1ML - Milliliter68788-8507f79c51dc-8872-4990-b24a-0bf2fe4d379212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8507LIDOCAINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240621_55aa77b8-7601-4432-8631-bfec58daf247.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine HCl 2 % Oral Topical SolutionSY55aa77b8-7601-4432-8631-bfec58daf2474
1010739lidocaine HCl 2 % Oromucosal SolutionSY55aa77b8-7601-4432-8631-bfec58daf2474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8507-168788850701100 mL in 1 BOTTLE (68788-8507-1) 100 ml2023-08-16NoNoCurrent