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 9 of 45 · 892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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