NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product NDC
0378-7308
11-digit product format
003787308
Labeler code
0378
Product ID
0378-7308_dd233955-5be5-4025-a841-66378e261dd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol and ferrous fumarate
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203371
Marketing category
ANDA
Marketing start
2015-04-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7308-53EA - Each0378-73088c6816e6-2b70-49a5-b1f6-bc636b3673f912015-05-05
0378-7308-85EA - Each0378-73085afd1f5e-a7a2-470d-8951-213cea24a3dc12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
NORETHINDRONEACTIVE INGREDIENTT18F433X4SNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ( NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ) KIT [MYLAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7308NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT [MYLAN PHARMACEUTICALS INC.]6Legacy NDC20250523_c89388f0-ffe4-4058-a644-3f43fb4d021b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7308-53003787308533 POUCH in 1 CARTON (0378-7308-53) > 1 KIT in 1 POUCH (0378-7308-85) 3 pouch2015-04-010000-00-00NoNoCurrent