FDA.reportPublic FDA data

Pruradik

Product NDC
73352-051
11-digit product format
733520051
Labeler code
73352
Product ID
73352-051_36991086-14b5-9e66-e063-6394a90ad654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Crotamiton
Dosage form
LOTION
Route
TOPICAL
Labeler
Trifluent Pharma, LLC
Application
ANDA087204
Marketing category
ANDA
Marketing start
2025-06-02
Substance
CROTAMITON
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pruradik
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROTAMITON100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD6S4O4XD0H
Rxcui106219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ea7942c-f3b4-4c60-49a3-bfc71c3c134eProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-051-10Pruradik237 g in 1 BOTTLE, PLASTICLOTION2371

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-051-10GM - Gram73352-05154bc029c-0b60-45ea-8c4e-733a6418aceb12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106219crotamiton 10 % Topical LotionPSN3699175f-bfc8-a047-e063-6394a90a80d11
106219crotamiton 100 MG/ML Topical LotionSCD3699175f-bfc8-a047-e063-6394a90a80d11
106219crotamiton 10 % Topical LotionSY3699175f-bfc8-a047-e063-6394a90a80d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-051-1073352005110237 g in 1 BOTTLE, PLASTIC (73352-051-10) 237 g2025-06-02NoNoCurrent