FDA.reportPublic FDA data

NDC 0378-7283-85 - NORETHINDRONE ACETATE 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
0378-7283
Requested NDC
0378-7283-85
Package NDCs from labels
0378-7283-85, 0378-7283-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-01-19HUMAN PRESCRIPTION DRUG LABEL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL - A-S Medication SolutionsA-S Medication Solutions2019-11-05HUMAN PRESCRIPTION DRUG LABEL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL - A-S Medication SolutionsA-S Medication Solutions2018-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7283-53NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL3 in 1 CARTONKIT312
0378-7283-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL1 in 1 POUCHKIT112
0378-7283-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7283NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC, 3 package rows20250221_2376cab5-3d34-4a0a-9ba1-df19a96eb5dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7283-53EA - Each0378-72833dedd15c-ec75-4d6a-8619-ea4c83c2382012014-08-01
0378-7283-85EA - Each0378-72835440c685-4f4f-4695-ac3e-52d136e3525712021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ( NORETHINDRONE ACETATE 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 1 of 41 · 813 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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