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 8 of 39 · 765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Norethindrone AcetateNORETHINDRONE ACETATEGlenmark Pharmaceuticals Inc., USAd0a94321-eb60-4aa6-a429-f0156f9f8e012026-01-29Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Norethindrone AcetateNORETHINDRONE ACETATEAmerican Health Packagingeb0b80e0-5b69-4efa-ae8a-62e718a62dc32026-01-14Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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