TRETINOIN

Product NDC
53002-8101
11-digit product format
530028101
Labeler code
53002
Product ID
53002-8101_d2bb8e19-80f5-4286-ba13-7ea2a6c3e090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075264
Marketing category
ANDA
Marketing start
2017-06-15
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
0 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
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
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-8101-12025-01-30C16284748780-12cef2736-7171-d83d-e063-dadaa90ab31fTretinoin Gel, USP and Tretinoin Cream, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8101-1TRETINOIN20 g in 1 TUBECREAM201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8101TRETINOIN CREAM [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220331_b1bfadb8-2622-4eb1-b69e-477c4ed82c6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1
106302tretinoin 0.25 MG/ML Topical CreamSCDb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1
106302tretinoin 0.025 % Topical CreamSYb1bfadb8-2622-4eb1-b69e-477c4ed82c6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8101-15300281010120 g in 1 TUBE (53002-8101-1) 20 g2022-10-010000-00-00NoNoCurrent