TARINA Fe 1/20

Product NDC
50102-128
11-digit product format
501020128
Labeler code
50102
Product ID
50102-128_40295acc-300e-44d9-a71e-5b9bae5bdba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol
Dosage form
KIT
Labeler
Afaxys Pharma, LLC.
Application
ANDA202772
Marketing category
ANDA
Marketing start
2014-09-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50102-128DDiscontinued by firm2026-07-31
excluded packagepackage50102-12850102-128-03DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202772-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL-28AB2013-11-14

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A202772-001AB

FDA-Initiated Inactive NDC Indexing#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50102-128-03501020128033 POUCH in 1 CARTON (50102-128-03) > 1 KIT in 1 POUCH (50102-128-01) 3 pouch2014-09-150000-00-00NoNoCurrent