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 10 of 12 · 239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: H4N855PNZ1
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.142c4b90-c9ab-45ce-9172-f1ea7d3666862023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.1ba8a8ab-eb09-0807-47d4-6b4055d10d912023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLXiromed, LLC.e1586633-1973-c396-6f4a-4c55cce4b59e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSXiromed, LLC.da872266-d5f2-35df-096e-341f58d934272023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 748798
rxcui: 630734
YasminDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.d7ea6a60-5a56-4f81-b206-9b27b7e588752023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NextstellisDROSPIRENONE AND ESTETROLMayne Pharmac5270073-d083-4109-ae4b-156986175e0a2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-VyLibra LoNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCbd51a08e-cd45-4315-9bca-41794450ef162023-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP9c4fac8e-8744-4378-80af-7887de955a512023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgetsrel and Ethinyl EstradiolLEVONORGETSREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.b04e1404-6eee-48f3-a51e-66de3fc95b602023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepackc607816d-0da9-4960-9723-69f28aa3f2f22023-03-02Boxed warningExact identifier
rxcui: 748797
VolneaDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.d7f3a118-4a1a-786e-c1db-01a0c2f2189d2023-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions51e4270a-1b91-4ff8-9a50-ffe49204b6b42023-02-21Boxed warning, WarningsExact identifier
rxcui: 748797
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.7dbc4cdf-4ce2-5c66-343f-df381f56692a2023-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.4701e72b-6378-a771-fb88-1b703031a8bc2023-02-10Boxed warningExact identifier
rxcui: 748797
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLA-S Medication Solutionscfa297a6-1cc7-4751-b8ea-0e57965f1ca92023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f82023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd38f31bb-faba-40a8-bc60-2f78f2875ef22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AranelleNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.0beef9d3-8326-48cf-b89a-fa794902c6c12023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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