FDA.reportPublic FDA data

NDC 69238-1633-01 - Estradiol

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
69238-1633
Requested NDC
69238-1633-01
Package NDCs from labels
69238-1633-1, 69238-1633-7, 69238-1633-01
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC
Effective date
2024-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2024-05-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1633-1Estradiol1 d in 1 POUCHPATCH, EXTENDED RELEASE117
69238-1633-7Estradiol8 in 1 CARTONPATCH, EXTENDED RELEASE817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1633ESTRADIOL PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]17Current NDC, Legacy NDC, 2 package rows20240607_0500ee9b-bf4a-4432-9afe-20a7d60a6fe5.zip

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 4 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLDirect_Rx47e446f8-ac16-ea6b-e063-6394a90a17262026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLC106b92da-334c-542f-e063-6394a90aa65b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLC0a1e744c-7926-0e0c-e063-6294a90a80d02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLCf6caf47a-1917-c493-e053-6394a90af63e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthwind Health Company, LLCf6cb38ab-fdff-9c07-e053-6294a90ad59a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNorthwind Health Company, LLCf76aff99-f415-9045-e053-6294a90afd512026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: FZ989GH94E
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
unii: FZ989GH94E
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: FZ989GH94E
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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