FDA.reportPublic FDA data

NDC 0555-9010-79 - Nortrel 21 Day

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
0555-9010
Requested NDC
0555-9010-79
Package NDCs from labels
0555-9010-79, 0555-9010-58
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2021-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nortrel ® (norethindrone and ethinyl estradiol tablets USP)Teva Pharmaceuticals USA, Inc.2021-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9010-58Nortrel28 Day6 in 1 CARTONKIT616
0555-9010-79Nortrel28 Day1 in 1 POUCHKIT116
0555-9010-79Nortrel28 Day1 in 1 BLISTER PACKKIT116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9010NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20250316_140c50d6-c931-423a-9aa0-526eae7ab93c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9010-58EA - Each0555-9010027e2804-3c7f-4345-9e1f-3d0a0ba6105412012-07-24
0555-9010-79EA - Each0555-901075d6464b-d24c-464b-ae9d-6c5072cbe37712017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
NORETHINDRONEACTIVE INGREDIENTT18F433X4SNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
NORETHINDRONEACTIVE MOIETYT18F433X4SNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTREL (21 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL (28 DAY REGIMEN) (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5

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 9 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited22cfceff-0429-466f-a015-33cfdc505d442024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.71f90c73-63c2-432b-b112-cbdbd26b965c2023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
RhuzdahNORETHINDRONE AND ETHINYL ESTRADIOL TABLETAurobindo Pharma Limiteddea10e78-0e7b-4404-9c3a-ed2447a1788b2023-11-23Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Lo-ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limiteda8c718cc-e235-4710-a9e6-6c58433f30282023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited192ad3b0-9ef2-409d-a851-77712202c45a2023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonestLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsdfda3568-b626-4194-b0af-df5d2ea69e3f2023-10-03Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.25f9b952-cc1d-454e-a3ec-834ba1774b6b2023-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.a1f6ea0e-7c14-47c4-83a2-3797bd012eb42023-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.142c4b90-c9ab-45ce-9172-f1ea7d3666862023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.1ba8a8ab-eb09-0807-47d4-6b4055d10d912023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLXiromed, LLC.e1586633-1973-c396-6f4a-4c55cce4b59e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSXiromed, LLC.da872266-d5f2-35df-096e-341f58d934272023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YasminDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.d7ea6a60-5a56-4f81-b206-9b27b7e588752023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NextstellisDROSPIRENONE AND ESTETROLMayne Pharmac5270073-d083-4109-ae4b-156986175e0a2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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