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 3 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VesturaDROSPIRENONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd52026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTRELLEVONORGESTRELCamber Consumer Care Inc2e22d0c4-b308-4a02-b2b0-2c06fb91d1e52026-03-23WarningsExact identifier
unii: 5W7SIA7YZW
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
SkylaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.9f44ff35-e052-49cd-a1c2-0bfd87d493092026-03-04Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf73ece43-6b5f-4abb-ba6d-4d62775f2f8e2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions6edead7f-a41f-4d0b-a27a-b2047ed4eea02026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
RestartLEVONORGESTRELWinx Health Inc.0cdf198e-c114-b9fa-e063-6294a90a566a2026-02-24WarningsExact identifier
unii: 5W7SIA7YZW
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.47fc432b-2259-47d2-bba9-5e3aae5839902026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonorgestrelLEVONORGESTRELYYBA Corp49008f10-8a70-3c08-e063-6294a90a44a32026-02-03WarningsExact identifier
unii: 5W7SIA7YZW
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
BRIELLYNNORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAc0e2c5b4-70ac-4b41-aa71-00e506dbb72f2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA39988aa6-8f68-40e8-9bdd-c40a3bdaad612026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5c02b4d3-1e2f-439a-ae45-02304ee190d12026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA3d87d9a4-860a-4ea7-a993-0f4adf1789da2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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