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 5 of 12 · 239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 748798
rxcui: 630734
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
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b91ad328-f2f4-4f7d-82d3-daaada95f5092025-07-28Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevoraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.31679b9f-58c9-4bf1-8c2c-f5a216ff4cd32025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SRONYXLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b0c1a495-4cd7-4664-8fe4-714812f53c712025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Hemorrhoid CreamHEMORRHOID CREAMHenan Shouerkang Health Industry Co., Ltd426c0602-63a5-104b-e063-6294a90ae9642025-07-07WarningsExact identifier
unii: H4N855PNZ1
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack241fb1e2-c0da-47b8-b502-2cb17976d7c02025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YazDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.065f33e4-b587-4e66-b896-ca9ab7b7c8762025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 748798
rxcui: 630734
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.00dd9b78-dd90-414b-b241-7619aa9d1ed22025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
St. Paul Brands VerestorVITAMIN C,VITAMIN E,NATTOKINASE,PHYTOSTEROL,DOKUDAMI LEAF,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals0e0b6c75-0ae8-4ef4-ab86-0f3be5ca63d12025-03-31WarningsExact identifier
unii: H4N855PNZ1
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
PortiaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.c78b236b-85c4-4258-a524-cea08775100c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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