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 9 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
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 unii: 9S44LIC7OJ
Jinteli	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	d667ca75-1a17-43fc-9077-f25ce0908f8d	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
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 application number: NDA020870 ndc (product): 68968-0514 rxcui: 1251495 rxcui: 1251501 rxcui: 1251499 rxcui: 1251493 spl id: a8dddb67-4c56-4d1d-a4ce-83dc426d33f6 spl set id: 83198ef1-11c4-11e4-9191-0800200c9a66 unii: 4TI98Z838E unii: 9S44LIC7OJ
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 unii: 9S44LIC7OJ
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	3108a9bc-3378-459d-8f6b-bd5eff2ad657	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	89948751-bd6e-4e9c-b87c-8782706c1097	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
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
Norethindrone acetate	NORETHINDRONE ACETATE	Ingenus Pharmaceuticals, LLC	2f39b608-cc62-4ff0-a52a-bc3343275269	2023-12-04	Warnings, Adverse reactions	Exact identifier unii: 9S44LIC7OJ
Activella	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals LLC	d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E unii: 9S44LIC7OJ

Reported adverse events (FAERS/openFDA)#

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