FDA.reportPublic FDA data

Layolis Fe

Product NDC
52544-064
11-digit product format
525440064
Labeler code
52544
Product ID
52544-064_5f54ff08-9e07-4085-9980-04895ba6826d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone, ethinyl estradiol, and ferrous fumarate
Dosage form
KIT
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA022573
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-12-23
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-064-31EA - Each52544-064bf822132-fd3c-4a29-b22f-c751d77d817e12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
NORETHINDRONEACTIVE INGREDIENTT18F433X4SLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
NORETHINDRONEACTIVE MOIETYT18F433X4SLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NLAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52544-064LAYOLIS FE (NORETHINDRONE, ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [ACTAVIS PHARMA, INC.]9Legacy NDC20240329_c0db84ca-b8d4-4ed2-b2f6-19347283146e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52544-064-31525440064313 BLISTER PACK in 1 CARTON (52544-064-31) > 1 KIT in 1 BLISTER PACK3 blister pack2011-12-230000-00-00NoNoCurrent