Lidocaine and Prilocaine

Product NDC
21695-388
11-digit product format
216950388
Labeler code
21695
Product ID
21695-388_b61c6a09-7764-4a92-93a9-a1356aeeaa9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA076453
Marketing category
ANDA
Marketing start
2009-11-06
Marketing end
0000-00-00
Substance
LIDOCAINE; PRILOCAINE
Active strength
25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-388-302019-09-24C16284748780-1934fe258-4d85-48b1-e053-8cdaa90a720aLIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-388-30Lidocaine and Prilocaine1 in 1 CARTONCREAM11
21695-388-30Lidocaine and Prilocaine30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-388-30GM - Gram21695-388236f837f-1374-49a7-84a9-a47260fccace12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-388LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101123_b61c6a09-7764-4a92-93a9-a1356aeeaa9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNb61c6a09-7764-4a92-93a9-a1356aeeaa9c1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDb61c6a09-7764-4a92-93a9-a1356aeeaa9c1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYb61c6a09-7764-4a92-93a9-a1356aeeaa9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-388-30216950388301 in 1 CARTONHistorical