vivelle-dot

Generic: estradiol

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vivelle-dot
Generic Name estradiol
Labeler sandoz inc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .075 mg/d

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-148
Product ID 66758-148_8e8ae172-5a0d-4888-a825-0c6cfa1afac9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020538
Listing Expiration 2026-12-31
Marketing Start 1999-01-08

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 66758148
Hyphenated Format 66758-148

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 284378 310172 310176 310183 1149632 1149634
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 vivelle-dot (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA020538 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .075 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 BOX (66758-148-83) / 1 PATCH in 1 POUCH (66758-148-58) / 3.5 d in 1 PATCH
source: ndc

Packages (1)

66758-148-83 8 POUCH in 1 BOX (66758-148-83) / 1 PATCH in 1 POUCH (66758-148-58) / 3.5 d in 1 PATCH

Ingredients (1)

estradiol (.075 mg/d)

Linked Drug Pages (1)

Vivelle-Dot ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "8e8ae172-5a0d-4888-a825-0c6cfa1afac9", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "284378", "310172", "310176", "310183", "1149632", "1149634"], "spl_set_id": ["5ccb77f9-d47b-4381-ad5c-5b92524e1c4a"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 BOX (66758-148-83)  / 1 PATCH in 1 POUCH (66758-148-58)  / 3.5 d in 1 PATCH", "package_ndc": "66758-148-83", "marketing_start_date": "20240701"}], "brand_name": "Vivelle-Dot", "product_id": "66758-148_8e8ae172-5a0d-4888-a825-0c6cfa1afac9", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "66758-148", "generic_name": "estradiol", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vivelle-Dot", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".075 mg/d"}], "application_number": "NDA020538", "marketing_category": "NDA", "marketing_start_date": "19990108", "listing_expiration_date": "20261231"}