FDA.reportPublic FDA data

NDC 57297-854-11 - Levonorgestrel and Ethinyl Estradiol

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
57297-854
Requested NDC
57297-854-11
Package NDCs from labels
57297-854-11, 57297-854-13
Manufacturer
LUPIN LIMITED
Effective date
2016-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levonorgestrel and Ethinyl Estradiol - LUPIN LIMITEDLUPIN LIMITED2016-05-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57297-854-132024-12-09C16284748780-19d75b9d0-9a36-f424-e053-dadaa90a57ceLevonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg
57297-854-132020-01-31C16284748780-19d75b9d0-9a36-f424-e053-dadaa90a57ceLevonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg

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 1 of 9 · 164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
unii: 5W7SIA7YZW
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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