FDA.reportPublic FDA data

NDC 51862-545-01 - SRONYX

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
51862-545
Requested NDC
51862-545-01
Package NDCs from labels
51862-545-01, 51862-545-06
Manufacturer
Mayne Pharma Inc. | Patheon Inc.
Effective date
2025-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SRONYX ® (Levonorgestrel and Ethinyl Estradiol Tablets USP)Mayne Pharma Inc. | Patheon Inc.2025-07-24HUMAN PRESCRIPTION DRUG LABEL
SRONYX ® (Levonorgestrel and Ethinyl Estradiol Tablets USP)RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-545-01SRONYX1 in 1 BLISTER PACKKIT18
51862-545-06SRONYX6 in 1 CARTONKIT68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-545SRONYX (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]7Current NDC, Legacy NDC, 2 package rows20220309_b0c1a495-4cd7-4664-8fe4-714812f53c71.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-545-01EA - Each51862-5450fe45b1e-3c77-41b7-97bd-e67643e24ebd12018-01-12
51862-545-06EA - Each51862-5453f5f4cd5-4dc7-48a5-b89d-eb822a6e56c712016-09-02

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 6 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
TurqozNORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.5eecfd2c-4bda-4349-b634-199a354fa9962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
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
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
ElinestNORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCaa7f4a83-71cf-4306-b0a1-01784f67bae22025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
My WayLEVONORGESTRELLupin Pharmaceuticals, Inc.3efec61d-e0a6-49c5-9b88-834db6d171fd2025-12-02WarningsExact identifier
unii: 5W7SIA7YZW
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bb96f0-d5f1-1ec3-e063-6294a90a74b12025-11-26WarningsExact identifier
unii: 5W7SIA7YZW
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
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bbad6f-0c54-e4ed-e063-6394a90af3ad2025-11-14WarningsExact identifier
unii: 5W7SIA7YZW
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

Reported adverse events (FAERS/openFDA)#

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