NDC 68968-6675-08 - Minivelle

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: 68968-6675
Requested NDC: 68968-6675-08
Package NDCs from labels: 68968-6675-8, 68968-6675-08
Manufacturer: Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.
Effective date: 2026-07-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Minivelle - Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL
Sharp Corporation blanket no changes certification of product listing	Sharp Corporation	2017-10-12	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68968-6675-8	Minivelle	8 in 1 PACKET	FILM, EXTENDED RELEASE	8		19
68968-6675-8	Minivelle	1 d in 1 POUCH	FILM, EXTENDED RELEASE	1		19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68968-6675	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	19	Current NDC, Legacy NDC, 2 package rows	20240224_6c5c47ab-28ee-11e1-bfc2-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-6675-1	EA - Each	68968-6675	2f922438-7867-4be6-bde5-beaf6c79f9a8	1	2015-11-12
68968-6675-8	EA - Each	68968-6675	e9ac996e-abe5-4a34-aaf4-be49dcc97289	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	4

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 10 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aurovela 1.5/30	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	b146e49c-a0fc-4f3d-9ad6-99e8257fa139	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
Aurovela 1/20	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	6765becf-7b51-4f33-ac13-70fcd01decf7	2023-11-21	Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
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
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Exact identifier rxcui: 1149632 rxcui: 242892 rxcui: 242891 rxcui: 248478 rxcui: 241946 unii: 4TI98Z838E
Norethindrone Acetate	NORETHINDRONE ACETATE	Teva Pharmaceuticals USA, Inc.	f73f9807-4af6-4faa-ba9a-656a47a4c5e0	2022-11-30	Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
HGH 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, 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-fcf736643fc6	2022-03-28	Warnings	Exact identifier unii: 4TI98Z838E
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	45ebb59c-9603-4df6-b1be-3295ba2db1e7	2021-01-29	Warnings, Adverse reactions	Exact identifier unii: 207ZZ9QZ49
GUNA-PMS	ARSENIC 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 spa	86f341b1-a8f7-4833-a1be-e51610b05bcd	2018-12-21	Warnings	Exact identifier unii: 4TI98Z838E
Lopreeza	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	bf0e39cb-95e7-4831-92d2-0b3f071aeaae	2017-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E unii: 9S44LIC7OJ
Estrogen and Progesterone	AGNUS 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 ALBUM	ProBLEN	71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf	2017-01-12	Warnings	Exact identifier unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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