FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
52565-007
11-digit product format
525650007
Labeler code
52565
Product ID
52565-007_de4a6eae-ba69-4f23-9cb1-9a827cbdbd6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA205887
Marketing category
ANDA
Marketing start
2018-06-29
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
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-007-072023-01-30C16284748780-1f386c64a-3e26-0266-e053-dadaa90a7c1aLidocaine and Prilocaine USP, 2.5%/2.5%
52565-007-302023-01-30C16284748780-1f386c64a-3e26-0266-e053-dadaa90a7c1aLidocaine and Prilocaine USP, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-007-07Lidocaine and Prilocaine5 in 1 CARTONCREAM53
52565-007-07Lidocaine and Prilocaine5 g in 1 TUBECREAM53
52565-007-30Lidocaine and Prilocaine1 in 1 CARTONCREAM13
52565-007-30Lidocaine and Prilocaine30 g in 1 TUBECREAM303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-007-07GM - Gram52565-007debcb466-ce7a-4db5-a4f8-4c4ede69bee112018-12-13
52565-007-30GM - Gram52565-0078b71ed7d-d313-4bb5-9a5d-f531d6636dc012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-007LIDOCAINE AND PRILOCAINE CREAM [TELIGENT PHARMA, INC.]3Legacy NDC, 4 package rows20181121_7a790e8b-ff12-411f-bacc-9141d4dfef58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN7a790e8b-ff12-411f-bacc-9141d4dfef583
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD7a790e8b-ff12-411f-bacc-9141d4dfef583
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY7a790e8b-ff12-411f-bacc-9141d4dfef583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-007-07525650007075 TUBE in 1 CARTON (52565-007-07) > 5 g in 1 TUBE5 tube2018-06-290000-00-00NoNoCurrent
52565-007-30525650007301 TUBE in 1 CARTON (52565-007-30) > 30 g in 1 TUBE1 tube2018-06-290000-00-00NoNoCurrent