FDA.reportPublic FDA data

NDC 70518-3922-01 - 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
70518-3922
Requested NDC
70518-3922-01
Package NDCs from labels
70518-3922-0, 70518-3922-1, 70518-3922-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Tablets, USP Rx onlyREMEDYREPACK INC.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3922-0Estradiol30 in 1 BLISTER PACKTABLET305
70518-3922-1Estradiol90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3922ESTRADIOL TABLET [REMEDYREPACK INC.]4Current NDC, 2 package rows20250115_59a4b68d-a507-4809-a0c8-fd9799986d12.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 28 of 38 · 751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LymphoplusTRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEADeseret Biologicals, Inc.92f6fc6b-58c0-4137-88b3-bee2118aeb292024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.a1b42f4b-4029-4008-b950-a7725f34b43d2024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: ETJ7Z6XBU4
ESTRADIOLESTRADIOLBryant Ranch Prepack0e927450-3f02-4d2f-9235-a255357e8d932024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepack6a4e82a4-d980-4c04-9e33-9444a292728a2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackeab9a629-b3d4-4faf-bce4-656fe3b46d382024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.a98082ba-21ec-4cf8-b81c-bcb41eb9fd122024-04-23WarningsExact identifier
unii: ETJ7Z6XBU4
LigaparLAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUMEnergique, Inc.17f6b1f5-8e49-49df-bad4-9c19fa677e692024-04-22WarningsExact identifier
unii: ETJ7Z6XBU4
VisioparEUPHRASIA OFFICINALIS, EYE (SUIS), AURUM METALLICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, MAGNESIA CARBONICA, PHOSPHORUS, SILICEA, PHYSOSTIGMA VENENOSUM, OSMIUM METALLICUM, THUJA OCCIDENTALISEnergique, Inc.811f7626-0d21-49bd-8c31-9a5abec45c132024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3fe899db-a8cd-4a31-88fb-1129be96b4d92024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217334
ndc (product): 70954-565
rxcui: 197657
rxcui: 197658
rxcui: 197659
spl id: 6b381113-0e63-42e0-aeb7-d339e798f444
spl set id: 3fe899db-a8cd-4a31-88fb-1129be96b4d9
unii: 4TI98Z838E
EstradiolESTRADIOLNoven Therapeutics, LLCbf185599-2138-4083-9c52-2b95dce09ae02024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197657
rxcui: 197658
rxcui: 197659
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197657
unii: 4TI98Z838E
VAXR HCTHUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODEDeseret Biologicals, Inc.fdf8d21a-2ae1-4842-abf3-7378419959392024-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
YUVAFEMESTRADIOLAmneal Pharmaceuticals LLC30c7f6ba-7a9e-4853-b3e4-e00a465602242024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals of New York LLC094830ee-1b1c-4cf7-8a39-427dfd56f9c92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.8cb31c7c-fba8-4201-833d-844ea1a8a4de2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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