NDC 17139-613

EstroGel

Estradiol

EstroGel is a Transdermal Gel, Metered in the Human Prescription Drug category. It is labeled and distributed by Ascend Therapeutics Us, Llc. The primary component is Estradiol.

• Product ID: 17139-613_74285ccb-8cb6-4c29-a5ec-1fe1999658b6
• NDC: 17139-613
• Product Type: Human Prescription Drug
• Proprietary Name: EstroGel
• Generic Name: Estradiol
• Dosage Form: Gel, Metered
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2004-02-09
• Marketing Category: NDA / NDA
• Application Number: NDA021166
• Labeler Name: ASCEND Therapeutics US, LLC
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 1 mg/1.25g
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC SPL Data Element Entries

NDC 17139-613-50 [17139061350]

EstroGel GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021166
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-24
• Marketing End Date: 2014-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.75 mg/1.25g

OpenFDA Data

• SPL SET ID: 87bb0e2f-9fa6-438b-9d5f-d0a90af770ed
• Manufacturer:
  • ASCEND Therapeutics US, LLC
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 226597
  • 581549

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
17139-617	EstroGel	EstroGel
17139-613	EstroGel	EstroGel
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