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 12 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd19ff955-1778-43c7-a111-476d740dc9d92019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC46bbdf70-2b80-4359-a19b-d94ff99eac982016-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC59bce25b-ee2c-4f06-afff-e5141d0636022016-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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