NDC 68968-6610 – Minivelle
Estradiol .1 mg/d · Film, Extended Release · Transdermal
Product NDC68968-6610
Product details
- Brand name
- Minivelle
- Generic name
- Estradiol
- Labeler
- Noven Therapeutics, LLC
- Dosage form
- Film, Extended Release
- Route
- Transdermal
- Marketing category
- NDA · NDA203752
- Marketed since
- December 20, 2012
- Listing expires
- December 31, 2027
- Pharmacologic class
- Estrogen
Active ingredients
- Estradiol .1 mg/d
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 68968-6610-8 | 8 POUCH in 1 PACKET (68968-6610-8) / 1 d in 1 POUCH | Dec 20, 2012 |
Recalls mentioning this NDC
- D-0336-2021 Apr 28, 2021 · Class II
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience… - D-1207-2018 Oct 3, 2018 · Class II
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - D-1210-2018 Oct 3, 2018 · Class II
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - D-1208-2018 Oct 3, 2018 · Class II
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - D-1209-2018 Oct 3, 2018 · Class II
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. - D-0862-2018 May 16, 2018 · Class II
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that… - D-0863-2018 May 16, 2018 · Class II
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that… - D-0923-2017 Jul 5, 2017 · Class III
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. - D-0485-2015 Apr 22, 2015 · Class II
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Other Minivelle products
- 68968-6625 Estradiol .025 mg/d · Film, Extended Release · Noven Therapeutics, LLC
- 68968-6637 Estradiol .0375 mg/d · Film, Extended Release · Noven Therapeutics, LLC
- 68968-6650 Estradiol .05 mg/d · Film, Extended Release · Noven Therapeutics, LLC
- 68968-6675 Estradiol .075 mg/d · Film, Extended Release · Noven Therapeutics, LLC