FDA.reportPublic FDA data

NDC 0480-5794 - 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
0480-5794
Package NDCs from labels
0480-5794-22
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

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 6 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
6cb4094e-229d-480f-884f-40b4a4bb407bb5d48561-1aa1-4c9b-935f-6cf0352257692024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 6cb4094e-229d-480f-884f-40b4a4bb407b
spl set id: b5d48561-1aa1-4c9b-935f-6cf035225769
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC2417aee4-6838-4ea6-8e0d-3144f522310c2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d9252820-131a-4870-8b11-945d1bfd56592024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 748797
KalligaDESOGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddbe9f9ab-2e38-49e3-bb1f-c8a12d03076a2024-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NYLIA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions4ade84c1-e172-443f-aac7-0e8407aaa7de2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JoyeauxLEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC655b2c93-cfae-d44f-c128-c816bbd88e452024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SIMLIYADESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited4161f614-6e55-4114-87f7-19bb77f6b09b2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP411e6e51-b435-4f86-b39f-3377f009b0e92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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