NDC 0574-2067 – Evamist
Estradiol 1.53 mg/1 · Spray · Transdermal
Product NDC0574-2067
Product details
- Brand name
- Evamist
- Generic name
- Estradiol
- Labeler
- Padagis US LLC
- Dosage form
- Spray
- Route
- Transdermal
- Marketing category
- NDA · NDA022014
- Marketed since
- April 11, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Estrogen
Active ingredients
- Estradiol 1.53 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0574-2067-00 sample | 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00) | Apr 11, 2015 |
| 0574-2067-27 | 56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27) | Apr 11, 2015 |
Recalls mentioning this NDC
- D-0464-2023 Mar 22, 2023 · Class III
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. - D-0608-2018 Apr 4, 2018 · Class II
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.