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 7 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 748797
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSDr. Reddys Laboratories Inc.fb636d42-cc1d-47f7-974d-c97c79207f3e2024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedea9f7216-0358-43a9-96eb-5dad694ae9b82024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JasmielDROSPIRENONE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC1a3211f8-41f5-4905-a466-0d79add5fdad2024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutionsa45ee86e-69ca-49a5-8990-5dde52d4a5222024-05-07Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions33b895e4-b467-41b1-a812-8068cc5bb93e2024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions9b1f944b-b05b-4ab0-bcf6-42f426b07c452024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf4f8ea-1eb3-4a43-87d2-16f93e9044432024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075840
rxcui: 748797
rxcui: 749786
rxcui: 311359
rxcui: 750265
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

Reported adverse events (FAERS/openFDA)#

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