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 6 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALTYA 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC207dfcf6-5239-c907-e5fe-35372da57dd92025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VALTYA 1/50ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC1aff28b0-93eb-5e44-9164-d76ffd08cd592025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC2417aee4-6838-4ea6-8e0d-3144f522310c2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d9252820-131a-4870-8b11-945d1bfd56592024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 748797
KalligaDESOGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddbe9f9ab-2e38-49e3-bb1f-c8a12d03076a2024-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NYLIA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions4ade84c1-e172-443f-aac7-0e8407aaa7de2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 312033
rxcui: 310463
JoyeauxLEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC655b2c93-cfae-d44f-c128-c816bbd88e452024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SIMLIYADESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited4161f614-6e55-4114-87f7-19bb77f6b09b2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP411e6e51-b435-4f86-b39f-3377f009b0e92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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