FDA.reportPublic FDA data

NDC 0378-7308-85 - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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
0378-7308
Requested NDC
0378-7308-85
Package NDCs from labels
0378-7308-85, 0378-7308-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NORETHINDRONE AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-01-15HUMAN PRESCRIPTION DRUG LABEL

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

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

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 7 of 35 · 687 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
NorethindroneNORETHINDRONEGlenmark Pharmaceuticals Inc., USA0d2f8fea-3675-40d2-afd9-9fcb148dbd4b2026-01-31Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
HEATHERNORETHINDRONEGlenmark Pharmaceuticals Inc., USA35b5ddb5-1729-4588-b2a2-ead56d78b6f92026-01-23Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
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

Reported adverse events (FAERS/openFDA)#

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