FDA.reportPublic FDA data

NDC 0378-7274-85 - 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
0378-7274
Requested NDC
0378-7274-85
Package NDCs from labels
0378-7274-85, 0378-7274-53
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, 1.5 mg/0.03 mgMylan Pharmaceuticals Inc.2024-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7274-53NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL3 in 1 CARTONTABLET36
0378-7274-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL1 in 1 POUCHTABLET16
0378-7274-85NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL21 in 1 BLISTER PACKTABLET216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7274NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250221_3108a9bc-3378-459d-8f6b-bd5eff2ad657.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7274-53EA - Each0378-727469756ed9-63ef-4c23-95dd-81b86ce817fa12019-10-07
0378-7274-85EA - Each0378-7274c7bd30bf-48a1-49ec-82af-d4d2f591715612019-10-07

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 2 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone AcetateNORETHINDRONE ACETATEGlenmark Pharmaceuticals Inc., USAd0a94321-eb60-4aa6-a429-f0156f9f8e012026-01-29Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Hailey Fe 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGlenmark Pharmaceuticals Inc., USA84f6d573-3022-4982-aaa4-ac69393210a22026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone AcetateNORETHINDRONE ACETATEAmerican Health Packagingeb0b80e0-5b69-4efa-ae8a-62e718a62dc32026-01-14Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Larin 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOLNorthstar Rx LLCe232ed29-e6f5-4591-8d61-68eb8b1596f02025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
Larin Fe 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATENorthstar Rx LLCee79a7fa-1c64-4b7b-822c-e0ddefc8ef862025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
BLISOVI FE 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.5c5f2307-8679-4e34-9bcd-c22219b14a152025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
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
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
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

Reported adverse events (FAERS/openFDA)#

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