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 8 of 12 · 239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf0323be5-9654-4236-8164-230f51a028cd2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norethindrone and ethinyl estradiolNORETHINDRONE AND ETHINYL ESTRADIOLNaari Pte Limited9bd9119e-a874-41e2-ac58-b7f0d155d2fb2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLNaari Pte. Limitedd96f0dd8-4eb9-42f7-ab5e-b5515dcf73d62024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiol and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNaari Pte. Limitedf8961550-d103-8ee6-e053-6294a90a75712024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLDr. Reddy's Laboratories Inc.1ca12bf6-9583-4578-8411-51ad02a405ec2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KarivaDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.7b11e11f-6977-4109-b9bd-a066e5d1278a2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions4d888008-cc14-4291-b384-0d482f48eb082024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
Tri-VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCf59acc3e-21d9-4fa3-ad52-d77225739e1a2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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