NDC 0574-2067

Evamist

Estradiol

Evamist is a Transdermal Spray in the Human Prescription Drug category. It is labeled and distributed by Paddock Laboratories, Llc. The primary component is Estradiol.

• Product ID: 0574-2067_0f2eac49-acfa-4ac3-a3f1-cb2f7745c5f5
• NDC: 0574-2067
• Product Type: Human Prescription Drug
• Proprietary Name: Evamist
• Generic Name: Estradiol
• Dosage Form: Spray
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2015-04-11
• Marketing Category: NDA / NDA
• Application Number: NDA022014
• Labeler Name: Paddock Laboratories, LLC
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0574-2067-00

56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)

• Marketing Start Date: 2015-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0574-2067-00 [00574206700]

Evamist SPRAY

• Marketing Category: NDA
• Application Number: NDA022014
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-04-11

NDC 0574-2067-27 [00574206727]

Evamist SPRAY

• Marketing Category: NDA
• Application Number: NDA022014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-04-11

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	1.53 mg/1

OpenFDA Data

• SPL SET ID: 9a0aa631-133d-406b-9d32-8a1a99af4e50
• Manufacturer:
  • Paddock Laboratories, LLC
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 728122
  • 728118

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 "Evamist" or generic name "Estradiol"

NDC	Brand Name	Generic Name
0574-2067	Evamist	Evamist
64011-215	Evamist	Evamist
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