NDC 68968-6637

Minivelle

Estradiol

Minivelle is a Transdermal Film, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Noven Therapeutics, Llc. The primary component is Estradiol.

• Product ID: 68968-6637_30ab0454-1dcf-4df5-a7f8-309011db4e62
• NDC: 68968-6637
• Product Type: Human Prescription Drug
• Proprietary Name: Minivelle
• Generic Name: Estradiol
• Dosage Form: Film, Extended Release
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2012-12-20
• Marketing Category: NDA / NDA
• Application Number: NDA203752
• Labeler Name: Noven Therapeutics, LLC
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 0 mg/d
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68968-6637-8

8 POUCH in 1 PACKET (68968-6637-8) > 1 d in 1 POUCH (68968-6637-1)

• Marketing Start Date: 2012-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68968-6637-8 [68968663708]

Minivelle FILM, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203752
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-20

NDC 68968-6637-3 [68968663703]

Minivelle FILM, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203752
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-12-20
• Marketing End Date: 2014-10-07

NDC 68968-6637-1 [68968663701]

Minivelle FILM, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA203752
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-20

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.0375 mg/d

OpenFDA Data

• SPL SET ID: 6c5c47ab-28ee-11e1-bfc2-0800200c9a66
• Manufacturer:
  • Noven Therapeutics, LLC
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 1551622
  • 1357009
  • 242891
  • 248478
  • 242892
  • 1356979
  • 1356997
  • 241946
  • 1357007
  • 1149632
• UPC Code:
  • 0368968661016
  • 0368968667513
  • 0368968665014
  • 0368968663713

Pharmacological Class

• Estradiol Congeners [CS]
• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]

Medicade Reported Pricing

68968663708 MINIVELLE 0.0375 MG PATCH

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Minivelle" or generic name "Estradiol"

NDC	Brand Name	Generic Name
68968-6650	Minivelle	Minivelle
68968-6675	Minivelle	Minivelle
68968-6637	Minivelle	Minivelle
68968-6610	Minivelle	Minivelle
68968-6625	Minivelle	Minivelle
0023-5885	Alora	Estradiol
0023-5886	Alora	Estradiol
0023-5887	Alora	Estradiol
0023-5888	Alora	Estradiol
0037-4801	ELESTRIN	ESTRADIOL
0037-4802	ELESTRIN	ESTRADIOL
0013-2150	Estring	estradiol
0078-0343	Vivelle-Dot	estradiol
0078-0344	Vivelle-Dot	estradiol
0078-0345	Vivelle-Dot	estradiol
0078-0346	Vivelle-Dot	estradiol
0078-0365	Vivelle-Dot	estradiol