WYMZYA FE

Product NDC
68180-899
11-digit product format
681800899
Labeler code
68180
Product ID
68180-899_e4a8d988-7070-405e-8972-531ebc7636bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol, and ferrous fumarate
Dosage form
KIT
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021490
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-12-19
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-899-13WYMZYA FE1 in 1 BLISTER PACKKIT11
68180-899-13WYMZYA FE5 in 1 CARTONKIT51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-899-13EA - Each68180-89999fe9988-7749-4728-a4ab-b59789f4d57d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
NORETHINDRONEACTIVE INGREDIENTT18F433X4SWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
NORETHINDRONEACTIVE MOIETYT18F433X4SWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2WYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NWYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4WYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-899WYMZYA FE (NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [LUPIN PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20141206_2bbed452-3714-424f-87d4-b91b941b5381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486452{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack [Wymzya Fe 28 Day]BPCK2bbed452-3714-424f-87d4-b91b941b53811
1095224{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } PackGPCK2bbed452-3714-424f-87d4-b91b941b53811
1095224eth-estra-noreth 0.035-0.4 MG (21) Chewable Tablet / ferr fum 75 MG (7) Chewable Tablet 28 Day PackPSN2bbed452-3714-424f-87d4-b91b941b53811
1095223ferrous fumarate 75 MG Chewable TabletPSN2bbed452-3714-424f-87d4-b91b941b53811
433718norethindrone 0.4 MG / ethinyl estradiol 35 MCG Chewable TabletPSN2bbed452-3714-424f-87d4-b91b941b53811
1486452WYMZYA Fe 28 Day PackPSN2bbed452-3714-424f-87d4-b91b941b53811
433718ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable TabletSCD2bbed452-3714-424f-87d4-b91b941b53811
1095223ferrous fumarate 75 MG Chewable TabletSCD2bbed452-3714-424f-87d4-b91b941b53811
1095224{21 (ethinyl estradiol 35 MCG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } PackSY2bbed452-3714-424f-87d4-b91b941b53811
1486452Wymzya Fe 0.4 mg/35 mcg Chewable 28 Day PackSY2bbed452-3714-424f-87d4-b91b941b53811
1486452Wymzya Fe 28 Day PackSY2bbed452-3714-424f-87d4-b91b941b53811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68180-899-13681800899131 in 1 BLISTER PACKHistorical