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 10 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions51e4270a-1b91-4ff8-9a50-ffe49204b6b42023-02-21Boxed warning, WarningsExact identifier
rxcui: 748797
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.7dbc4cdf-4ce2-5c66-343f-df381f56692a2023-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.4701e72b-6378-a771-fb88-1b703031a8bc2023-02-10Boxed warningExact identifier
rxcui: 748797
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLA-S Medication Solutionscfa297a6-1cc7-4751-b8ea-0e57965f1ca92023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f82023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd38f31bb-faba-40a8-bc60-2f78f2875ef22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AranelleNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.0beef9d3-8326-48cf-b89a-fa794902c6c12023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP5f3dedb9-a500-4e21-8ffa-0d942243c7902023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.a522aff5-b02f-4e18-bf59-40bb0399e6fe2022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.b13800f2-618f-468d-b8a5-2fc00595db612022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.198477e0-855a-4a1d-ae0b-407568dd05f82022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.96a73786-22b1-457e-be73-80b699996d402022-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Velivet Triphasic RegimenDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a3ce5125-62ba-4983-93f0-91f2542716052022-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedd9d2d0a1-b336-40ee-b4cc-b3d876ca91b92022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 1/35NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb31bd776-3926-4b77-aa29-f5a8eef611aa2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LP5b684f8f-9610-4449-a213-f70bb4a04b8b2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075840
rxcui: 748797
rxcui: 749786
rxcui: 311359
rxcui: 750265
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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