FDA.reportPublic FDA data

NDC 50102-231-01 - Tri-VyLibra Lo

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
50102-231
Requested NDC
50102-231-01
Package NDCs from labels
50102-231-01, 50102-231-11, 50102-231-13
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2023-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tri-VyLibra Lo - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07Human Prescription Drug Label
Tri-VyLibra Lo - Afaxys Pharma, LLC | Aurobindo Pharma LimitedAfaxys Pharma, LLC | Aurobindo Pharma Limited2023-05-04Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50102-231-01Tri-VyLibra Lo1 in 1 BLISTER PACKKIT16
50102-231-11Tri-VyLibra Lo1 in 1 PACKAGEKIT16
50102-231-13Tri-VyLibra Lo3 in 1 CARTONKIT36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50102-231TRI-VYLIBRA LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AFAXYS PHARMA, LLC]6Current NDC, Legacy NDC, 3 package rows20230510_bd51a08e-cd45-4315-9bca-41794450ef16.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-231-01EA - Each50102-2310825a580-b531-4461-b2c7-2275e2b4f93012019-03-12
50102-231-11EA - Each50102-23127c4407b-0e3c-4d79-aeee-4e77cee8bded12019-02-13
50102-231-13EA - Each50102-23106ae543f-37da-4279-86a7-d92365ff077812019-02-13

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 90 of 118 · 2,342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
unii: 15FIX9V2JP
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
unii: 15FIX9V2JP
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
unii: 15FIX9V2JP
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
unii: 15FIX9V2JP
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
unii: 15FIX9V2JP
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incbe2a83fb-e4f8-4313-b5bd-150f351fb3452024-06-26WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
unii: 15FIX9V2JP
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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