FDA.reportPublic FDA data

NDC 60219-2387 - Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

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
60219-2387
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2023-07-18
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 - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2023-07-18HUMAN 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 · 237 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aurovela Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited83513d13-5352-4d86-9dfd-fd1e456087c02023-11-21Warnings, Adverse reactionsExact identifier
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: 1358762
rxcui: 259176
AUROVELA FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limiteddb3d0229-4581-46c0-82a8-7d022c1358262023-11-21Warnings, Adverse reactionsExact identifier
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
rxcui: 1359117
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1358762
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: 1358762
rxcui: 259176
rxcui: 1359117
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
ndc (package): 60219-1031-6
ndc (package): 60219-1031-7
ndc (product): 60219-1031
rxcui: 1358762
rxcui: 259176
rxcui: 1426288
rxcui: 1359117
spl id: ae13db8f-27e2-420a-b909-99d0347e6286
spl set id: d4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab
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
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
rxcui: 259176
rxcui: 1426288
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
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

Reported adverse events (FAERS/openFDA)#

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