FDA.reportPublic FDA data

NDC 0378-7280-85 - 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
0378-7280
Requested NDC
0378-7280-85
Package NDCs from labels
0378-7280-85, 0378-7280-53
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 Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mgMylan Pharmaceuticals Inc.2024-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7280-53NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL3 in 1 CARTONTABLET310
0378-7280-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL21 in 1 BLISTER PACKTABLET2110
0378-7280-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL1 in 1 POUCHTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7280NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20250221_89948751-bd6e-4e9c-b87c-8782706c1097.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7280-53EA - Each0378-7280c809bc41-de91-498e-9904-a5df9dcd033312014-08-01
0378-7280-85EA - Each0378-728000920816-31d5-4249-b91d-978f1e5f818212018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]3

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 8 · 149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone AcetateNORETHINDRONEAvKARE827c7ef1-a8b7-d0c4-b062-c5154b331a352025-09-17Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Tilia FeNDAC AND EE TABLETS AND FERROUS FUMARATE TABLETSMayne Pharma Inc.cebfb589-1b34-4f51-a0c8-c2c0cf4c71452025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
MyfembreeRELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATESumitomo Pharma America, Incfc3feb73-cc84-43a8-aa32-b262460495e82025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Microgestin Fe 1/20NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEMayne Pharma Inc.5bf28e22-8f58-4166-8a62-2717ecd6a70f2025-08-04Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Junel Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBryant Ranch Prepack13d7768b-ee41-46b0-93f4-5e8170dd338d2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202771
rxcui: 1358776
rxcui: 1358762
unii: 423D2T571U
unii: 9S44LIC7OJ
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358776
rxcui: 1358762
unii: 423D2T571U
unii: 9S44LIC7OJ
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358776
rxcui: 1358762
unii: 423D2T571U
unii: 9S44LIC7OJ
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
XARAH FENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE TABLETSXiromed LLC2c5cf9c3-948e-964b-7424-21c84461df932025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762

Reported adverse events (FAERS/openFDA)#

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