FDA.reportPublic FDA data

NDC 69238-2387 - Melodetta 24 Fe

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
69238-2387
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC
Effective date
2023-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Melodetta 24 Fe - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC2023-06-29HUMAN PRESCRIPTION DRUG LABEL

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 11 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aurovela 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited3eb092dc-2ec1-4d55-b1fe-69505608e04a2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.4423eebd-6397-4330-85a8-baa2e736767a2023-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
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: 259176
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
application number: ANDA207514
rxcui: 259176
rxcui: 1426288
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
rxcui: 1426288
rxcui: 1426600
Melodetta 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCca89a8e3-4df1-4e4b-9da7-0233770e542b2023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207514
ndc (package): 69238-1031-7
ndc (package): 69238-1031-6
ndc (product): 69238-1031
rxcui: 259176
rxcui: 1426288
rxcui: 1426600
rxcui: 1944656
spl id: ef7d6985-bc76-4ecc-9774-7edfacbef22c
spl set id: ca89a8e3-4df1-4e4b-9da7-0233770e542b
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: 259176
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
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: 259176
Norethindrone AcetateNORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.f73f9807-4af6-4faa-ba9a-656a47a4c5e02022-11-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ

Reported adverse events (FAERS/openFDA)#

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