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 96 of 118 · 2,342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
unii: 15FIX9V2JP
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
unii: 15FIX9V2JP
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: 15FIX9V2JP
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: 15FIX9V2JP
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
unii: 15FIX9V2JP
VolneaDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack0e65209d-329a-4d31-8afb-24348dc8d7e72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749157
rxcui: 748797
rxcui: 749155
rxcui: 749156
rxcui: 578732
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
unii: 15FIX9V2JP
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLBryant Ranch Prepack4424505f-acae-43ba-8a75-eadd0e283b232024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSBryant Ranch Prepacked92658d-87e3-4b5a-912f-0b51943da5e32024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: 15FIX9V2JP
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
unii: 15FIX9V2JP
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
unii: 15FIX9V2JP
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 15FIX9V2JP
Tri-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited22cfceff-0429-466f-a015-33cfdc505d442024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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