NDC 0078-0365

Vivelle-Dot

Estradiol

Vivelle-Dot is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Estradiol.

• Product ID: 0078-0365_2740040f-a14a-4b53-83f7-842dd443081f
• NDC: 0078-0365
• Product Type: Human Prescription Drug
• Proprietary Name: Vivelle-Dot
• Generic Name: Estradiol
• Dosage Form: Patch, Extended Release
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 1999-01-08
• Marketing Category: NDA / NDA
• Application Number: NDA020538
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 0 mg/d
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0365-42

8 POUCH in 1 BOX (0078-0365-42) > 1 PATCH in 1 POUCH (0078-0365-62) > 3.5 d in 1 PATCH

• Marketing Start Date: 2016-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0365-45 [00078036545]

Vivelle-Dot PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020538
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-01-08

NDC 0078-0365-62 [00078036562]

Vivelle-Dot PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020538
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-28

NDC 0078-0365-42 [00078036542]

Vivelle-Dot PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020538
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-27

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.025 mg/d

OpenFDA Data

• SPL SET ID: e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 310172
  • 242891
  • 248478
  • 242892
  • 241946
  • 1149632
  • 310176
  • 1149634
  • 284378
  • 310183

Pharmacological Class

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

NDC Crossover Matching brand name "Vivelle-Dot" or generic name "Estradiol"

NDC	Brand Name	Generic Name
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
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