FDA.reportPublic FDA data

NDC 0480-3629 - Vestura

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
0480-3629
Package NDCs from labels
0480-3629-11
Manufacturer
Teva Pharmaceuticals, Inc.
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vestura - Teva Pharmaceuticals, Inc.Teva Pharmaceuticals, Inc.2026-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3629-11Vestura24 in 1 BLISTER PACKTABLET243 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3629VESTURA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS, INC.]1Unmatched20241108_c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd5.zip

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 · 239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VolneaDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack0e65209d-329a-4d31-8afb-24348dc8d7e72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLBryant Ranch Prepack4424505f-acae-43ba-8a75-eadd0e283b232024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSBryant Ranch Prepacked92658d-87e3-4b5a-912f-0b51943da5e32024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 748798
rxcui: 630734
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
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
rxcui: 748798
rxcui: 630734
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
Pain FormulaSALIX ALBA, ASCORBICUM ACIDUM, VITAMIN A, VITAMIN E, ACETYLSALICYLICUM ACIDUMNutritional Specialties, Inc.0cc0d205-83c2-4205-a93c-6a8ba55956d42023-11-20WarningsExact identifier
unii: H4N855PNZ1
Lo-ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limiteda8c718cc-e235-4710-a9e6-6c58433f30282023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 748798
rxcui: 630734
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

Reported adverse events (FAERS/openFDA)#

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