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
Label	Manufacturer	Effective date	Type
Estradiol - Noven Therapeutics, LLC	Noven Therapeutics, LLC	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68968-3475-8	Estradiol	8 in 1 CARTON	FILM, EXTENDED RELEASE	8		6
68968-3475-8	Estradiol	1 d in 1 POUCH	FILM, EXTENDED RELEASE	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68968-3475	ESTRADIOL FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20240522_bf185599-2138-4083-9c52-2b95dce09ae0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-3475-1	EA - Each	68968-3475	fb711cdf-332b-4622-baae-dcc1c5e9b914	1	2018-12-13
68968-3475-8	EA - Each	68968-3475	8d9403f6-bc5d-4943-a3e7-9938f2923299	1	2018-12-13

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 8 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic	DHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSA	DMD Clinical Naturopathy	7679472c-bc6a-40c1-8e66-adc0b6ca18b4	2024-03-21	Warnings	Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1149632 rxcui: 242892 rxcui: 242891 rxcui: 248478 rxcui: 241946 unii: 4TI98Z838E
High Vitality	AGNUS 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, GABA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), APIOLUM,	Deseret Biologicals, Inc.	2fd79cc1-42ed-49f5-b9e1-c48dedd21b1c	2024-03-13	Warnings	Exact identifier unii: 4TI98Z838E
Etyqa	ESTRADIOL AND NORETHINDRONE ACETATE	Aurobindo Pharma Limited	afbc2a33-5eb2-4f01-91e9-07d8050da6ce	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
CombiPatch (estradiol/norethindrone acetate transdermal system)	ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM	Noven Therapeutics, LLC	83198ef1-11c4-11e4-9191-0800200c9a66	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol / Norethindrone Acetate	ESTRADIOL AND NORETHINDRONE ACETATE	Breckenridge Pharmaceutical, Inc.	44125b2f-10ac-435c-bdb4-a29bf8450dbf	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
High Vitality Tab	AGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, 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	4040e55f-9d59-483e-bba1-ec6cd6869375	2023-12-12	Warnings	Exact identifier unii: 4TI98Z838E
Activella	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals LLC	d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Vivelle-Dot	ESTRADIOL	Sandoz Inc	5ccb77f9-d47b-4381-ad5c-5b92524e1c4a	2023-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1149632 rxcui: 242892 rxcui: 242891 rxcui: 248478 rxcui: 241946 unii: 4TI98Z838E
Lipotox	SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,	BioActive Nutritional, Inc.	a1538692-ca00-4e52-9b7e-409767ee27e1	2023-09-05	Warnings	Exact identifier unii: 4TI98Z838E
Estrogen 4X	ESTRADIOL	Nutritional Specialties, Inc.	772c2a8a-10e2-49af-8db6-4d5ca64b1719	2023-07-25	Warnings	Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Exact identifier unii: 4TI98Z838E
Young Again	AGNUS 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,	Dr. Donna Restivo DC	b29089e4-83e1-49ab-b5dd-2ef7fbb008e3	2023-01-10	Warnings	Exact identifier unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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