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 3 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MARLISSALEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA9379d99e-c416-4dab-a817-1c110e0d4b932026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutionsf7f7c073-48e0-4065-970b-8103d76b6eb02026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LPfa32e05b-c86d-4743-aee5-be3fc515152b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
OpillNORGESTRELRedpharm Drug303264da-c919-e0ce-e063-6394a90a4cc72025-12-25WarningsExact identifier
unii: 3J8Q1747Z2
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA6d85f252-307c-4aa8-9572-1e74c98192832025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ENSKYCEDESOGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.799fa1d8-4e7b-4b5e-844d-d638896a4b022025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.bc402baa-5de4-4149-9857-081a9b4eb2802025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.c25cd86c-2940-475a-9628-ee75b0294e8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e686b50-8d36-4a13-91a8-d4ad21cdb7352025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NikkiDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.9aff6034-044c-466d-bf52-18a998d47f662025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PIMTREADESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNorthstar Rx LLCb716fd2a-b186-447a-85bd-6302284d14e52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TurqozNORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.5eecfd2c-4bda-4349-b634-199a354fa9962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749786
rxcui: 311359
Dasetta 1/35NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCbfadc9b6-1dd6-4bf3-af5f-b50fbdae55d32025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonestLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCbe7000f1-5bf1-4de5-a256-e4436c37f0a12025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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