FDA.reportPublic FDA data

Tretinoin

Product NDC
21695-804
11-digit product format
216950804
Labeler code
21695
Product ID
21695-804_f5ce22e8-1a9b-408c-86ae-4084b7afeca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA075265
Marketing category
ANDA
Marketing start
1998-12-24
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
1 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
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
21695-804-202019-09-24C16284748780-1934fe258-4728-48b1-e053-8cdaa90a720aTretinoin Gel, USP Tretinoin Cream, USP Rx only For External Use Only. Not For Ophthalmic Use.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-804-20Tretinoin20 g in 1 TUBECREAM201
21695-804-20Tretinoin1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-804-20GM - Gram21695-804fa5c8a38-ed11-4884-b970-ff29dc2f16eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
BRUCINE SULFATEINACTIVE INGREDIENTKY7O12XPOQTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-804TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120511_f5ce22e8-1a9b-408c-86ae-4084b7afeca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
313451tretinoin 0.025 % Topical GelPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.05 % Topical CreamPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
313451tretinoin 0.00025 MG/MG Topical GelSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106302tretinoin 0.25 MG/ML Topical CreamSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.5 MG/ML Topical CreamSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106302tretinoin 0.025 % Topical CreamSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11
313451tretinoin 0.025 % Topical GelSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.05 % Topical CreamSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-804-202169508042020 g in 1 TUBE20 gHistorical