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 4 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
ElinestNORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCaa7f4a83-71cf-4306-b0a1-01784f67bae22025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JuleberDESOGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCde9a2d1b-15f6-453f-b36b-1c2a43c4918d2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSMayne Pharma Inc.d0d2a9e9-e9ce-4a42-b429-5c1f9a5447952025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLMayne Pharma Inc.e80714f4-cdfe-4d60-a4e1-b8c7b184cc462025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749879
rxcui: 310463
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMayne Pharma Inc.bff09a7b-aea6-460b-a263-44576e00f5102025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack5bebc7e2-d085-410c-bae1-7d758d3c20162025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AyunaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited2b54ce42-db64-46c3-a788-569e21f7ab062025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC61207a91-8b3c-4231-b98f-3cb9f4a4be092025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfirmelleLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddd6122cd-b7ba-4fe3-bde5-910882475b672025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Chateal EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC4c59652c-49a6-4eed-b557-9abd3ffac5412025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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