FDA.reportPublic FDA data

NDC 65862-897-28 - NYLIA 7/7/7

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
65862-897
Requested NDC
65862-897-28
Package NDCs from labels
65862-897-28, 65862-897-92, 65862-897-88
Manufacturer
A-S Medication Solutions
Effective date
2024-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NYLIA 7/7/7 - A-S Medication SolutionsA-S Medication Solutions2024-10-25Human Prescription Drug Label
Nylia 7/7/7 - Aurobindo Pharma LimitedAurobindo Pharma Limited2022-07-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-897-28Nylia 7/7/71 in 1 BLISTER PACKKIT18
65862-897-28Nylia 7/7/71 in 1 POUCHKIT18
65862-897-88Nylia 7/7/73 in 1 CARTONKIT38
65862-897-88Nylia 7/7/71 in 1 POUCHKIT18
65862-897-92Nylia 7/7/76 in 1 CARTONKIT68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-897NYLIA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 5 package rows20220703_867c5630-51be-4469-bf79-6a5cd4302cfa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-897-28EA - Each65862-897b5199eaf-7528-457d-a076-95893829afc812021-01-08
65862-897-88EA - Each65862-8970fd52d24-4ca1-40cd-af60-d0108f74152412021-01-08

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 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VALTYA 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC207dfcf6-5239-c907-e5fe-35372da57dd92025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VALTYA 1/50ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC1aff28b0-93eb-5e44-9164-d76ffd08cd592025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC2417aee4-6838-4ea6-8e0d-3144f522310c2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d9252820-131a-4870-8b11-945d1bfd56592024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 748797
KalligaDESOGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddbe9f9ab-2e38-49e3-bb1f-c8a12d03076a2024-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NYLIA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions4ade84c1-e172-443f-aac7-0e8407aaa7de2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207054
ndc (package): 50090-6321-0
ndc (product): 50090-6321
rxcui: 748797
rxcui: 312033
rxcui: 310463
rxcui: 1856424
rxcui: 749852
rxcui: 392662
spl id: 28662081-c05e-4eaa-8317-1325d470d6cb
spl set id: 4ade84c1-e172-443f-aac7-0e8407aaa7de
JoyeauxLEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC655b2c93-cfae-d44f-c128-c816bbd88e452024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SIMLIYADESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited4161f614-6e55-4114-87f7-19bb77f6b09b2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP411e6e51-b435-4f86-b39f-3377f009b0e92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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