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 5 of 45 · 892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
PRENATE DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENTAvion Pharmaceuticals, LLC8f2eca71-9a82-4a19-9206-36a04b865fe12026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7QWA1RIO01
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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