FDA.reportPublic FDA data

Tretinoin

Product NDC
42254-151
11-digit product format
422540151
Labeler code
42254
Product ID
42254-151_342ed5ed-2a53-4fc0-84f5-52b4094e1319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA017522
Marketing category
ANDA
Marketing start
2006-01-05
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
0 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
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
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
42254-151-202019-09-24C16284748780-19350213a-3da0-c013-e053-90daa90a1393TRETINOIN CREAM TRETINOIN GEL - FOR TOPICAL USE ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-151-20Tretinoin1 in 1 CARTONCREAM11
42254-151-20Tretinoin20 g in 1 TUBECREAM201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-151-20GM - Gram42254-1510f37c0a0-1033-4002-99cc-765ca3fd60e212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-151TRETINOIN CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120411_342ed5ed-2a53-4fc0-84f5-52b4094e1319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106303tretinoin 0.05 % Topical CreamPSN342ed5ed-2a53-4fc0-84f5-52b4094e13191
106303tretinoin 0.5 MG/ML Topical CreamSCD342ed5ed-2a53-4fc0-84f5-52b4094e13191
106303tretinoin 0.05 % Topical CreamSY342ed5ed-2a53-4fc0-84f5-52b4094e13191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-151-20422540151201 in 1 CARTONHistorical