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 6 of 8 · 149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CombiPatch (estradiol/norethindrone acetate transdermal system)ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEMNoven Therapeutics, LLC83198ef1-11c4-11e4-9191-0800200c9a662024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Junel Fe 24NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Pharmaceuticals USA, Inc.ffbf48de-0f61-49f9-9cd5-6eb8e08040db2024-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202771
ndc (package): 0378-7280-85
ndc (package): 0378-7280-53
ndc (product): 0378-7280
ndc11 (package): 00378728085
rxcui: 1358776
rxcui: 1358762
spl id: e450353d-021c-b48d-d1ea-0787a1561ae2
spl set id: 89948751-bd6e-4e9c-b87c-8782706c1097
unii: 423D2T571U
unii: 9S44LIC7OJ
Quflora PediatricVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDECarWin Pharmaceutical Associates, LLCb8e08798-d8bb-4616-996b-a2c07a5d730a2024-01-10Warnings, Adverse reactionsExact identifier
unii: 7QWA1RIO01
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEA-S Medication Solutions421b8cf7-119f-495a-b10a-bd864e87ab5a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Norethindrone acetateNORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC2f39b608-cc62-4ff0-a52a-bc33432752692023-12-04Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Aurovela Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited83513d13-5352-4d86-9dfd-fd1e456087c02023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Tarina Fe 1/20 EQNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAfaxys Pharma, LLCed7dd100-a339-41bc-91be-6d20b73dbce62023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Aurovela 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited3eb092dc-2ec1-4d55-b1fe-69505608e04a2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1358776
rxcui: 1358762
unii: 423D2T571U
unii: 9S44LIC7OJ
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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