Lidocaine

Product NDC
17478-711
11-digit product format
174780711
Labeler code
17478
Product ID
17478-711_cabfb396-7b14-40b5-a647-634e907e2d3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
Akorn
Application
ANDA040433
Marketing category
ANDA
Marketing start
2003-08-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-711-10Lidocaine1 in 1 CARTONJELLY18
17478-711-10Lidocaine5 mL in 1 TUBEJELLY58
17478-711-30Lidocaine1 in 1 CARTONJELLY18
17478-711-30Lidocaine30 mL in 1 TUBE, WITH APPLICATORJELLY308
17478-711-31Lidocaine10 in 1 CARTONJELLY108
17478-711-31Lidocaine5 mL in 1 TUBEJELLY58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-711-10ML - Milliliter17478-711c3d33659-1892-4ac2-9e7c-97c2466ae6c612012-07-24
17478-711-30ML - Milliliter17478-71106b9955a-242d-4216-a70f-ea70550576ad12012-07-24
17478-711-31ML - Milliliter17478-7113f0c6e2c-db02-4a07-b9da-e7144837a00c12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
LidocaineACTIVE MOIETY98PI200987LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-711LIDOCAINE (LIDOCAINE HYDROCHLORIDE) JELLY [AKORN]8Legacy NDC, 6 package rows20220914_317a8784-5fdd-429f-9b74-14d89f372a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN3ca876de-04bf-43e4-95d4-a58acc0d26c510
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD3ca876de-04bf-43e4-95d4-a58acc0d26c510
1011852lidocaine hydrochloride 2 % Topical JellySY3ca876de-04bf-43e4-95d4-a58acc0d26c510
1011852lidocaine HCl 2 % Topical GelPSN317a8784-5fdd-429f-9b74-14d89f372a328
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD317a8784-5fdd-429f-9b74-14d89f372a328
1011852lidocaine hydrochloride 2 % Topical JellySY317a8784-5fdd-429f-9b74-14d89f372a328
1011852lidocaine HCl 2 % Topical GelPSNd397fcf6-49f0-4bf6-a326-4b9698a778591
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDd397fcf6-49f0-4bf6-a326-4b9698a778591
1011852lidocaine hydrochloride 2 % Topical JellySYd397fcf6-49f0-4bf6-a326-4b9698a778591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-711-10174780711101 TUBE in 1 CARTON (17478-711-10) > 5 mL in 1 TUBE1 tube2003-08-010000-00-00NoNoCurrent
17478-711-30174780711301 TUBE, WITH APPLICATOR in 1 CARTON (17478-711-30) > 30 mL in 1 TUBE, WITH APPLICATOR2003-08-010000-00-00NoNoCurrent
17478-711-311747807113110 TUBE in 1 CARTON (17478-711-31) > 5 mL in 1 TUBE10 tube2018-05-020000-00-00NoNoCurrent