FDA.reportPublic FDA data

NDC 68968-3475-08 - 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
68968-3475
Requested NDC
68968-3475-08
Package NDCs from labels
68968-3475-8, 68968-3475-08
Manufacturer
Noven Therapeutics, LLC
Effective date
2024-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Noven Therapeutics, LLCNoven Therapeutics, LLC2024-04-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-3475-8Estradiol8 in 1 CARTONFILM, EXTENDED RELEASE86
68968-3475-8Estradiol1 d in 1 POUCHFILM, EXTENDED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-3475ESTRADIOL FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]6Current NDC, Legacy NDC, 2 package rows20240522_bf185599-2138-4083-9c52-2b95dce09ae0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-3475-1EA - Each68968-3475fb711cdf-332b-4622-baae-dcc1c5e9b91412018-12-13
68968-3475-8EA - Each68968-34758d9403f6-bc5d-4943-a3e7-9938f292329912018-12-13

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 9 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLZydus Lifesciences Limitedb79fd5ea-962f-491c-b670-40efe42ccf792022-12-07Exact identifier
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
unii: 4TI98Z838E
ESTRADIOLESTRADIOLAsclemed USA, Inc.229b4ec5-d3c8-4406-9fc5-8f633c6447b82022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPharmPak, Inc.8f8c5a0b-4d7b-a5cb-e053-2995a90a494e2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
HGH VitalityAGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE,Deseret Biologicals, Inc.8b6077c2-ecab-441a-8196-fcf736643fc62022-03-28WarningsExact identifier
unii: 4TI98Z838E
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
unii: 4TI98Z838E
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estrogen and ProgesteroneAGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMProBLEN71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf2017-01-12WarningsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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