FDA.reportPublic FDA data

NDC 65162-358-01 - ZAFEMY

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
65162-358
Requested NDC
65162-358-01
Package NDCs from labels
65162-358-01, 65162-358-03
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZAFEMY - Bryant Ranch PrepackBryant Ranch Prepack2024-01-05HUMAN PRESCRIPTION DRUG LABEL
ZAFEMY - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2022-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-358-01ZAFEMY7 d in 1 PATCHPATCH77
65162-358-01ZAFEMY1 in 1 POUCHPATCH17
65162-358-03ZAFEMY3 in 1 CARTONPATCH37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-358ZAFEMY (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 3 package rows20250427_5ee34c07-65af-42b8-a98f-e299ff90a8a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-358-01EA - Each65162-3587a70063e-cd4b-4ed1-8327-9c464dff61e012021-04-08
65162-358-03EA - Each65162-358abed0d70-21af-4fcf-a33b-2168f17ead6112021-03-02

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R0TAY3X631
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1534809
unii: R0TAY3X631
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
rxcui: 1534809
unii: R0TAY3X631
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213950
rxcui: 1534809
rxcui: 2531285
unii: R0TAY3X631
unii: 423D2T571U
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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