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 8 of 35 · 687 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rose Quartz 8142ROSE QUARTZProfessional Complementary Health Formulas898cd57d-8656-457d-92ff-5b4ea13578002026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4

Reported adverse events (FAERS/openFDA)#

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