FDA.reportPublic FDA data

NDC 50090-3237-00 - Junel Fe 28 Day

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
50090-3237
Requested NDC
50090-3237-00
Package NDCs from labels
50090-3237-0, 50090-3237-00
Manufacturer
A-S Medication Solutions
Effective date
2023-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Junel Fe 28 Day - A-S Medication SolutionsA-S Medication Solutions2023-12-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3237-0JunelFe 28 Day1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3237JUNEL FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20231213_421b8cf7-119f-495a-b10a-bd864e87ab5a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3237-0EA - Each50090-323759b3ead8-5e4e-463e-84f3-4ae7c666b83912022-02-07

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 9 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359028
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
rxcui: 1358776
rxcui: 1358762
unii: 423D2T571U
unii: 9S44LIC7OJ
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
application number: ANDA076081
ndc (package): 50090-3237-0
ndc (product): 50090-3237
ndc11 (package): 50090323700
rxcui: 1358763
rxcui: 1358762
rxcui: 259176
rxcui: 1358765
spl id: 294c23aa-b4fc-4f3f-a7a7-930268788cb1
spl set id: 421b8cf7-119f-495a-b10a-bd864e87ab5a
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
rxcui: 1359022
rxcui: 1359028
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: 1358763
rxcui: 1358762
rxcui: 259176
Tarina Fe 1/20 EQNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAfaxys Pharma, LLCed7dd100-a339-41bc-91be-6d20b73dbce62023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1358763
rxcui: 1358762
rxcui: 259176
AUROVELA FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limiteddb3d0229-4581-46c0-82a8-7d022c1358262023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359023
rxcui: 259176
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
rxcui: 259176
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
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.4423eebd-6397-4330-85a8-baa2e736767a2023-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359023
rxcui: 259176
TARINA 24 FENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAfaxys Pharma, LLC557fa655-c40f-4ecb-bd18-4820c7e15e4b2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
rxcui: 259176
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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