NDC 12822-0313

ANNOVERA

Segesterone Acetate, Ethinyl Estradiol

ANNOVERA is a Vaginal Ring in the Human Prescription Drug category. It is labeled and distributed by Qpharma Ab. The primary component is Segesterone Acetate; Ethinyl Estradiol.

• Product ID: 12822-0313_90b50883-bb8c-47a1-e053-2995a90a1651
• NDC: 12822-0313
• Product Type: Human Prescription Drug
• Proprietary Name: ANNOVERA
• Generic Name: Segesterone Acetate, Ethinyl Estradiol
• Dosage Form: Ring
• Route of Administration: VAGINAL
• Marketing Start Date: 2019-08-08
• Marketing Category: NDA / NDA
• Application Number: NDA209627
• Labeler Name: QPharma AB
• Substance Name: SEGESTERONE ACETATE; ETHINYL ESTRADIOL
• Active Ingredient Strength: 103 mg/1; mg/1
• Pharm Classes: Estrogen Receptor Agonists [MoA],Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 12822-0313-1

1 POUCH in 1 CARTON (12822-0313-1) > 1 RING in 1 POUCH

• Marketing Start Date: 2019-08-08
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

Active Ingredients

Ingredient	Strength
SEGESTERONE ACETATE	103 mg/1

OpenFDA Data

• SPL SET ID: 82dacbf8-5267-4c7f-bf1a-f5c755f64619
• Manufacturer:
  • QPharma AB
• UNII:
  • 9AMX4Q13CC
  • 423D2T571U
• UPC Code:
  • 0350261313013

Pharmacological Class

• Estrogen Receptor Agonists [MoA]
• Estrogen [EPC]

NDC Crossover Matching brand name "ANNOVERA" or generic name "Segesterone Acetate, Ethinyl Estradiol"

NDC	Brand Name	Generic Name
12822-0313	ANNOVERA	SEGESTERONE ACETATE, ETHINYL ESTRADIOL
50261-313	ANNOVERA	segesterone acetate and ethinyl estradiol