FDA.reportPublic FDA data

REFISSA

Product NDC
50224-002
11-digit product format
502240002
Labeler code
50224
Product ID
50224-002_09e54922-049f-48fe-953a-3320621413f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRETINOIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Suneva Medical, Inc.
Application
ANDA076498
Marketing category
ANDA
Marketing start
2009-06-17
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
2018-12-31
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
50224-002-022020-01-31C16284748780-19d75b9d0-75c7-f424-e053-dadaa90a57ceac92dfd3-6517-43d0-b6c1-b86fdf3a761f
50224-002-032020-01-31C16284748780-19d75b9d0-75c7-f424-e053-dadaa90a57ceac92dfd3-6517-43d0-b6c1-b86fdf3a761f
50224-002-042020-01-31C16284748780-19d75b9d0-67b1-f424-e053-dadaa90a57ceTretinoin Cream, USP (Emollient) 0.05%
50224-002-052020-01-31C16284748780-19d75b9d0-67b1-f424-e053-dadaa90a57ceTretinoin Cream, USP (Emollient) 0.05%
50224-002-062020-01-31C16284748780-19d75b9d0-75c7-f424-e053-dadaa90a57ceac92dfd3-6517-43d0-b6c1-b86fdf3a761f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50224-002-04Refissa60 g in 1 TUBECREAM601
50224-002-05Refissa40 g in 1 TUBECREAM401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50224-002-03GM - Gram50224-00227cc8e91-7343-47f0-b68f-4e8f2a88778b12013-06-04
50224-002-04GM - Gram50224-0020194d1a3-b1bf-4e48-ac79-5c0e4c46907012013-07-02
50224-002-05GM - Gram50224-00292ec8ce4-55e9-4ecb-8168-ed3defdde5bb12013-06-04
50224-002-06GM - Gram50224-0022a27a186-5a1b-47e4-9bc1-0dc4f2423fed12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
TRETINOINACTIVE MOIETY5688UTC01RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]3
TRETINOINACTIVE INGREDIENT5688UTC01RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
TRETINOINACTIVE MOIETY5688UTC01RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50224-002REFISSA (TRETINOIN) CREAM [SUNEVA MEDICAL, INC.]1Legacy NDC, 2 package rows20130104_357ed7c9-6ffa-45b8-94be-4d440f5a1c22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855687Refissa 0.05 % Topical CreamPSN357ed7c9-6ffa-45b8-94be-4d440f5a1c221
2117659tretinoin 0.05 % Emollient Base Topical CreamPSN357ed7c9-6ffa-45b8-94be-4d440f5a1c221
855687Emollient tretinoin 0.5 MG/ML Topical Cream [Refissa]SBD357ed7c9-6ffa-45b8-94be-4d440f5a1c221
2117659Emollient tretinoin 0.5 MG/ML Topical CreamSCD357ed7c9-6ffa-45b8-94be-4d440f5a1c221
855687Refissa 0.05 % Topical CreamSY357ed7c9-6ffa-45b8-94be-4d440f5a1c221
2117659tretinoin 0.05 % Emollient Base Topical CreamSY357ed7c9-6ffa-45b8-94be-4d440f5a1c221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50224-002-045022400020460 g in 1 TUBE60 gHistorical
50224-002-055022400020540 g in 1 TUBE40 gHistorical