Junel Fe 1.5/30

Product NDC
42254-242
11-digit product format
422540242
Labeler code
42254
Product ID
42254-242_eaf4191c-5b2f-47bd-b315-f695f8773260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Dosage form
KIT
Labeler
Rebel Distributors Corp
Application
ANDA076064
Marketing category
ANDA
Marketing start
2011-01-21
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
42254-242-28Junel Fe 1.5/301 in 1 BLISTER PACKKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-242-28EA - Each42254-2426d1b930e-52e1-4d31-8314-4a5ea3ef768a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
NORETHINDRONEACTIVE MOIETYT18F433X4SJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
ACACIAINACTIVE INGREDIENT5C5403N26OJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933JUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJJUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554JUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-242JUNEL FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130228_eaf4191c-5b2f-47bd-b315-f695f8773260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359025{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Junel Fe 1.5/30 28 Day]BPCKeaf4191c-5b2f-47bd-b315-f695f87732601
1359023{21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKeaf4191c-5b2f-47bd-b315-f695f87732601
1359023Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day PackPSNeaf4191c-5b2f-47bd-b315-f695f87732601
259176ferrous fumarate 75 MG Oral TabletPSNeaf4191c-5b2f-47bd-b315-f695f87732601
1359025Junel Fe 1.5/30 28 Day PackPSNeaf4191c-5b2f-47bd-b315-f695f87732601
1359022norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral TabletPSNeaf4191c-5b2f-47bd-b315-f695f87732601
1359022ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral TabletSCDeaf4191c-5b2f-47bd-b315-f695f87732601
259176ferrous fumarate 75 MG Oral TabletSCDeaf4191c-5b2f-47bd-b315-f695f87732601
1359022ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral TabletSYeaf4191c-5b2f-47bd-b315-f695f87732601
1359025Junel Fe 1.5/30 28 Day PackSYeaf4191c-5b2f-47bd-b315-f695f87732601
1359025Junel Fe 28 Day PackSYeaf4191c-5b2f-47bd-b315-f695f87732601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-242-28422540242281 in 1 BLISTER PACKHistorical