LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Product NDC
0378-7285
11-digit product format
003787285
Labeler code
0378
Product ID
0378-7285_29f407c5-994b-4e31-ac91-20497cf7b3cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levonorgestrel and ethinyl estradiol and ethinyl estradiol
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200492
Marketing category
ANDA
Marketing start
2015-05-28
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
0378-7285-85EA - Each0378-728571b51272-cc18-4724-a617-136b030b6d6312022-06-06
0378-7285-90EA - Each0378-72855a8bbb84-5882-4c96-b33c-3f2ad100108b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7285LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250221_e5eb2533-cc31-43a8-8fca-d46d72a59530.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7285-90003787285902 POUCH in 1 CARTON (0378-7285-90) > 1 BLISTER PACK in 1 POUCH (0378-7285-85) > 1 KIT in 1 BLISTER PACK2 pouch2015-05-280000-00-00NoNoCurrent