NDC 50261-104

IMVEXXY

Estradiol

IMVEXXY is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Therapeuticsmd, Inc.. The primary component is Estradiol.

• Product ID: 50261-104_259015d9-8736-4028-b93d-82c82fcd71a5
• NDC: 50261-104
• Product Type: Human Prescription Drug
• Proprietary Name: IMVEXXY
• Generic Name: Estradiol
• Dosage Form: Insert
• Route of Administration: VAGINAL
• Marketing Start Date: 2018-07-05
• Marketing Category: NDA / NDA
• Application Number: NDA208564
• Labeler Name: TherapeuticsMD, Inc.
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 4 ug/1
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50261-104-02

1 BLISTER PACK in 1 CARTON (50261-104-02) > 2 INSERT in 1 BLISTER PACK

• Marketing Start Date: 2018-08-10
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 50261-104-18 [50261010418]

IMVEXXY INSERT

• Marketing Category: NDA
• Application Number: NDA208564
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-10

NDC 50261-104-08 [50261010408]

IMVEXXY INSERT

• Marketing Category: NDA
• Application Number: NDA208564
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-10

NDC 50261-104-02 [50261010402]

IMVEXXY INSERT

• Marketing Category: NDA
• Application Number: NDA208564
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-10

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	4 ug/1

OpenFDA Data

• SPL SET ID: 104be9f2-a8f6-430e-9e01-2ee7cc1861f1
• Manufacturer:
  • TherapeuticsMD, Inc.
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 2054318
  • 2054316
  • 2054317
  • 2054315
  • 884707
  • 2048918
  • 2054310
  • 2054312
  • 2054313
  • 2048917
  • 2048916
  • 2054309

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
50261-110	IMVEXXY	IMVEXXY
50261-104	IMVEXXY	IMVEXXY
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