minivelle

Generic: estradiol

Labeler: noven therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name minivelle
Generic Name estradiol
Labeler noven therapeutics, llc
Dosage Form FILM, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .075 mg/d

Manufacturer
Noven Therapeutics, LLC

Identifiers & Regulatory

Product NDC 68968-6675
Product ID 68968-6675_58e55d14-a9df-4814-9b60-b7c9ce37b0b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203752
Listing Expiration 2026-12-31
Marketing Start 2012-12-20

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 689686675
Hyphenated Format 68968-6675

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632 1356979 1356997 1357007 1357009 1551622
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name minivelle (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA203752 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .075 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 PACKET (68968-6675-8) / 1 d in 1 POUCH
source: ndc

Packages (1)

68968-6675-8 8 POUCH in 1 PACKET (68968-6675-8) / 1 d in 1 POUCH

Ingredients (1)

estradiol (.075 mg/d)

Linked Drug Pages (1)

Minivelle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "58e55d14-a9df-4814-9b60-b7c9ce37b0b7", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632", "1356979", "1356997", "1357007", "1357009", "1551622"], "spl_set_id": ["6c5c47ab-28ee-11e1-bfc2-0800200c9a66"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Noven Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 PACKET (68968-6675-8)  / 1 d in 1 POUCH", "package_ndc": "68968-6675-8", "marketing_start_date": "20121220"}], "brand_name": "Minivelle", "product_id": "68968-6675_58e55d14-a9df-4814-9b60-b7c9ce37b0b7", "dosage_form": "FILM, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68968-6675", "generic_name": "estradiol", "labeler_name": "Noven Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Minivelle", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".075 mg/d"}], "application_number": "NDA203752", "marketing_category": "NDA", "marketing_start_date": "20121220", "listing_expiration_date": "20261231"}