FDA.reportPublic FDA data

NDC 0480-5793 - Cryselle

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
0480-5793
Package NDCs from labels
0480-5793-11
Manufacturer
Teva Pharmaceuticals, Inc.
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cryselle ® (norgestrel and ethinyl estradiol tablets, USP)Teva Pharmaceuticals, Inc.2026-09-04HUMAN PRESCRIPTION DRUG LABEL
Cryselle - A-S Medication SolutionsA-S Medication Solutions2026-03-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-5793-11Cryselle21 in 1 BLISTER PACKTABLET210.3 mg1
0480-5793-11Cryselle21 in 1 BLISTER PACKTABLET210.3 mg1

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 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Lo-ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limiteda8c718cc-e235-4710-a9e6-6c58433f30282023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
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
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
application number: ANDA075840
rxcui: 748797
rxcui: 749786
rxcui: 311359
rxcui: 750265
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

Reported adverse events (FAERS/openFDA)#

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