FDA.reportPublic FDA data

NDC 50102-128-01 - TARINA Fe 1/20

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
50102-128
Requested NDC
50102-128-01
Package NDCs from labels
50102-128-01, 50102-128-03
Manufacturer
Afaxys Pharma, LLC. | Mylan Laboratories Limited
Effective date
2021-01-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TARINA Fe 1/20 - Afaxys Pharma, LLC. | Mylan Laboratories LimitedAfaxys Pharma, LLC. | Mylan Laboratories Limited2021-01-27HUMAN PRESCRIPTION DRUG LABEL
TARINA Fe 1/20 - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50102-128-032023-02-09C16284748780-1f386c649-fbc5-0266-e053-dadaa90a7c1aTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
50102-128-032023-01-30C16284748780-1f386c649-fbc5-0266-e053-dadaa90a7c1aTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-128-01EA - Each50102-128981b731d-5f27-4c7b-9af9-9926e206e86712015-01-05
50102-128-03EA - Each50102-128308076ab-97aa-43d7-a78a-315a1b45980212014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
NORETHINDRONEACTIVE MOIETYT18F433X4STARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4

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 30 of 39 · 765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
unii: 423D2T571U
unii: 9S44LIC7OJ
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Silica marinaSILICON DIOXIDEBoiron81442e86-bef4-4992-e053-2a91aa0a24532023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d2b8f2-dce0-c136-e053-2991aa0a0fdb2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d31d98-dd71-870e-e053-2991aa0a0ce72023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3ffad-5be4-700a-e053-2991aa0a1cc92023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3206e-a893-3f0c-e053-2991aa0a149f2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3d6ca-8b63-2e63-e053-2991aa0a0e052023-11-15Exact identifier
unii: ETJ7Z6XBU4
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c31d465-caac-3a02-e053-2a95a90adb3b2023-11-03WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus SarcodeECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUSNutritional Specialties, Inc.2dfda48f-5795-4b98-8bb2-bf65273e89202023-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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