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 4 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
ElinestNORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCaa7f4a83-71cf-4306-b0a1-01784f67bae22025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749786
rxcui: 311359
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JuleberDESOGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCde9a2d1b-15f6-453f-b36b-1c2a43c4918d2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSMayne Pharma Inc.d0d2a9e9-e9ce-4a42-b429-5c1f9a5447952025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLMayne Pharma Inc.e80714f4-cdfe-4d60-a4e1-b8c7b184cc462025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMayne Pharma Inc.bff09a7b-aea6-460b-a263-44576e00f5102025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack5bebc7e2-d085-410c-bae1-7d758d3c20162025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AyunaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited2b54ce42-db64-46c3-a788-569e21f7ab062025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC61207a91-8b3c-4231-b98f-3cb9f4a4be092025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfirmelleLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddd6122cd-b7ba-4fe3-bde5-910882475b672025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Chateal EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC4c59652c-49a6-4eed-b557-9abd3ffac5412025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749786
rxcui: 311359

Reported adverse events (FAERS/openFDA)#

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