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 10 of 11 · 219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: C151H8M554
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.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: C151H8M554
Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab2023-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
rxcui: 259176
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETSXiromed, LLCb4bc4302-9484-465a-090d-47e1e0360b732023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Melodetta 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCca89a8e3-4df1-4e4b-9da7-0233770e542b2023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Tri-Legest Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.6f9d30d9-5553-4cbd-a099-ff045bc858212023-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1358762
rxcui: 259176
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
Vitrexyl plus IronFERROUS FUMARATE, FOLIC ACIDPureTek Corporationada43056-a3ce-e7de-e053-2a95a90aa0462023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
PureVit DualFe PlusFERROUS FUMARATE, POLYSACCHARIDE IRON COMPLEXPureTek Corporation71f63741-cad4-43b5-bb3e-c63a188d10a22023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Vitranol FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb81daf17-430b-6ba2-e053-2a95a90a768b2023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Vitrexate FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationb3637def-a701-673a-e053-2995a90a02d52023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Junel Fe 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEProficient Rx LP253c6b2e-2c93-4ee7-94a6-fd063c569c1f2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359025
rxcui: 1359023
rxcui: 259176

Reported adverse events (FAERS/openFDA)#

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