NDC 68025-083

DIVIGEL

Estradiol

DIVIGEL is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Vertical Pharmaceuticals, Llc. The primary component is Estradiol.

• Product ID: 68025-083_2fd2b39f-eead-45b5-9438-eb55956e4fe8
• NDC: 68025-083
• Product Type: Human Prescription Drug
• Proprietary Name: DIVIGEL
• Generic Name: Estradiol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-01-18
• Marketing Category: NDA / NDA
• Application Number: NDA022038
• Labeler Name: Vertical Pharmaceuticals, LLC
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 1 mg/.75g
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68025-083-07

7 PACKET in 1 CARTON (68025-083-07) > .75 g in 1 PACKET

• Marketing Start Date: 2019-01-18
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 68025-083-07 [68025008307]

DIVIGEL GEL

• Marketing Category: NDA
• Application Number: NDA022038
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-18

NDC 68025-083-30 [68025008330]

DIVIGEL GEL

• Marketing Category: NDA
• Application Number: NDA022038
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-18

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.75 mg/.75g

OpenFDA Data

• SPL SET ID: 59e610dc-883e-4f07-9ec6-a5841b0bf9fb
• Manufacturer:
  • Vertical Pharmaceuticals, LLC
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 153444
  • 723526
• UPC Code:
  • 0368025066303
  • 0368025065306
  • 0368025067300
  • 0368025083300

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
68025-067	DIVIGEL	DIVIGEL
68025-066	DIVIGEL	DIVIGEL
68025-083	DIVIGEL	DIVIGEL
68025-065	DIVIGEL	DIVIGEL
68025-086	DIVIGEL	DIVIGEL
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