Lidocaine

Product NDC
42291-378
11-digit product format
422910378
Labeler code
42291
Product ID
42291-378_6e2d4b5b-0ef8-4a0a-9cdd-19e782ca092d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
AvKARE, Inc.
Application
ANDA086724
Marketing category
ANDA
Marketing start
2013-03-25
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-378-352025-07-29C16284748780-13b156c62-261b-fb37-e063-e6dba90a4e07LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-378-35Lidocaine1 in 1 CARTONOINTMENT15
42291-378-35Lidocaine35.44 g in 1 TUBEOINTMENT35.445

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-378-35GM - Gram42291-378f7f4283b-1628-4961-9a2d-cf69d5d6319412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LidocaineACTIVE INGREDIENT98PI200987LIDOCAINE (LIDOCAINE) OINTMENT [AVKARE, INC.]2
LidocaineACTIVE MOIETY98PI200987LIDOCAINE (LIDOCAINE) OINTMENT [AVKARE, INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PLIDOCAINE (LIDOCAINE) OINTMENT [AVKARE, INC.]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLIDOCAINE (LIDOCAINE) OINTMENT [AVKARE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE (LIDOCAINE) OINTMENT [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-378LIDOCAINE OINTMENT [AVKARE, INC.]5Legacy NDC, 2 package rows20181122_42abc81b-668f-7ec4-f37f-bdc5ac43465d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1543069lidocaine 5 % Topical OintmentPSN42abc81b-668f-7ec4-f37f-bdc5ac43465d5
1543069lidocaine 0.05 MG/MG Topical OintmentSCD42abc81b-668f-7ec4-f37f-bdc5ac43465d5
1543069lidocaine 5 % Topical OintmentSY42abc81b-668f-7ec4-f37f-bdc5ac43465d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-378-35422910378351 TUBE in 1 CARTON (42291-378-35) > 35.44 g in 1 TUBE1 tube2015-09-210000-00-00NoNoCurrent