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 11 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Velivet Triphasic RegimenDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a3ce5125-62ba-4983-93f0-91f2542716052022-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedd9d2d0a1-b336-40ee-b4cc-b3d876ca91b92022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 1/35NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb31bd776-3926-4b77-aa29-f5a8eef611aa2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 312033
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LP5b684f8f-9610-4449-a213-f70bb4a04b8b2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 312033
rxcui: 310463
rxcui: 749852
rxcui: 392662
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited867c5630-51be-4469-bf79-6a5cd4302cfa2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207054
ndc (package): 65862-897-28
ndc (package): 65862-897-92
ndc (package): 65862-897-88
ndc (product): 65862-897
ndc11 (package): 65862089728
rxcui: 748797
rxcui: 312033
rxcui: 310463
rxcui: 1856424
rxcui: 749852
rxcui: 392662
spl id: bc9e730c-8402-43e3-9a17-5b4ccf717a4c
spl set id: 867c5630-51be-4469-bf79-6a5cd4302cfa
IntrovaleLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.f5bc2427-3a18-e3e6-a058-210688e9c4462022-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4e1927bd-378d-45dc-8b18-3dd57ccd2cb62022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Reclipsen 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a1e00bc6-7487-4057-9dcc-d0e2327d1d122022-01-04Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cb2021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.563297dc-f27b-46e3-83de-bade17473d622021-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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