FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Minivelle - Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.Noven Therapeutics, LLC | Noven Pharmaceuticals, Inc.2026-07-31HUMAN PRESCRIPTION DRUG LABEL
Sharp Corporation blanket no changes certification of product listingSharp Corporation2017-10-12BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-6675-8Minivelle8 in 1 PACKETFILM, EXTENDED RELEASE819
68968-6675-8Minivelle1 d in 1 POUCHFILM, EXTENDED RELEASE119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-6675MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]19Current NDC, Legacy NDC, 2 package rows20240224_6c5c47ab-28ee-11e1-bfc2-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-6675-1EA - Each68968-66752f922438-7867-4be6-bde5-beaf6c79f9a812015-11-12
68968-6675-8EA - Each68968-6675e9ac996e-abe5-4a34-aaf4-be49dcc9728912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EMINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]4
ESTRADIOLACTIVE MOIETY4TI98Z838EMINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]4
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVMINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EMINIVELLE (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 7 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone AcetateNORETHINDRONEAmneal Pharmaceuticals LLC64cb920c-36e8-4d62-9d08-3ddf3989d3132024-10-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3518120e-cc44-4d70-8a20-0ef2dce9a3c62024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstrogensESTRADIOL, FOLLICULINUM, OOPHORINUM (SUIS)Energique, Inc.e0686139-824f-42bc-8610-bb003d7edc3f2024-10-24WarningsExact identifier
unii: 4TI98Z838E
ESTROGEN PHENOLICESTRADIOL,Energique, Inc.716cd86c-af47-45a6-b710-fed421e78fb52024-10-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 4TI98Z838E
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
unii: 9S44LIC7OJ
EstradiolESTRADIOLBryant Ranch Prepack5e9bd73f-67db-44f9-a5ee-409eed765cd22024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
GallifreyNORETHINDRONE ACETATEXiromed LLC26130af6-221b-2349-81b6-0c0132d6e5242024-08-31Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
unii: 4TI98Z838E
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack75fc6d3a-49b6-47ad-b704-410692010d3a2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242891
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackb119df4a-c514-4804-b1a8-b09c6058e80d2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149632
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackf419192a-eb95-4087-9fe0-0eea639ef51b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 241946
unii: 4TI98Z838E
ESTRACEESTRADIOLA-S Medication Solutionsda52a602-f2a2-4382-be07-30351c58cc4b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack779751dc-243a-4dc2-ae67-3669f196b2052024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242892
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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