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 8 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Tri-VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCf59acc3e-21d9-4fa3-ad52-d77225739e1a2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
VolneaDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack0e65209d-329a-4d31-8afb-24348dc8d7e72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLBryant Ranch Prepack4424505f-acae-43ba-8a75-eadd0e283b232024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSBryant Ranch Prepacked92658d-87e3-4b5a-912f-0b51943da5e32024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited22cfceff-0429-466f-a015-33cfdc505d442024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.71f90c73-63c2-432b-b112-cbdbd26b965c2023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
RhuzdahNORETHINDRONE AND ETHINYL ESTRADIOL TABLETAurobindo Pharma Limiteddea10e78-0e7b-4404-9c3a-ed2447a1788b2023-11-23Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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