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 3 of 36 · 710 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Minovia MiniMINOVIA MINIOncora Pharma, LLC297673c1-23db-47b5-8cfb-aaecc07908382026-06-24Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
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
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: R5L488RY0Q
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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