NDC 0378-7296-85 - DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-7296
Requested NDC
0378-7296-85
Package NDCs from labels
0378-7296-85, 0378-7296-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DESOGESTREL AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2023-08-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7296-53DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL3 in 1 CARTONKIT317
0378-7296-85DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT117
0378-7296-85DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7296DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 3 package rows20250216_142c4b90-c9ab-45ce-9172-f1ea7d366686.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7296-53EA - Each0378-7296748277b3-288b-44b0-9ad0-58dc00ad40b812014-12-01
0378-7296-85EA - Each0378-7296fb9eeeb2-59ce-4a62-bf2e-14e800366e1d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
DESOGESTRELACTIVE MOIETY81K9V7M3A3DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 45 · 892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 759743
rxcui: 249357
rxcui: 248310
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AshlynaLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions2004a53d-3f62-4c33-813a-94b1567fe4652026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.