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 7 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 748797
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSDr. Reddys Laboratories Inc.fb636d42-cc1d-47f7-974d-c97c79207f3e2024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedea9f7216-0358-43a9-96eb-5dad694ae9b82024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JasmielDROSPIRENONE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC1a3211f8-41f5-4905-a466-0d79add5fdad2024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutionsa45ee86e-69ca-49a5-8990-5dde52d4a5222024-05-07Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749858
rxcui: 312033
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions33b895e4-b467-41b1-a812-8068cc5bb93e2024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA072695
rxcui: 748797
rxcui: 749879
rxcui: 751868
rxcui: 310463
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions9b1f944b-b05b-4ab0-bcf6-42f426b07c452024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf4f8ea-1eb3-4a43-87d2-16f93e9044432024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf0323be5-9654-4236-8164-230f51a028cd2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Norethindrone and ethinyl estradiolNORETHINDRONE AND ETHINYL ESTRADIOLNaari Pte Limited9bd9119e-a874-41e2-ac58-b7f0d155d2fb2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749858
rxcui: 312033

Reported adverse events (FAERS/openFDA)#

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