NDC 50261-313

ANNOVERA

Segesterone Acetate And Ethinyl Estradiol

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

• Product ID: 50261-313_17feae6d-baa1-4f2c-8989-c5400c2a1a88
• NDC: 50261-313
• Product Type: Human Prescription Drug
• Proprietary Name: ANNOVERA
• Generic Name: Segesterone Acetate And Ethinyl Estradiol
• Dosage Form: Ring
• Route of Administration: VAGINAL
• Marketing Start Date: 2019-08-12
• Marketing Category: NDA / NDA
• Application Number: NDA209627
• Labeler Name: TherapeuticsMD, Inc.
• Substance Name: ETHINYL ESTRADIOL; SEGESTERONE ACETATE
• Active Ingredient Strength: 17 mg/1; mg/1
• Pharm Classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50261-313-01

1 POUCH in 1 CARTON (50261-313-01) > 1 RING in 1 POUCH

• Marketing Start Date: 2019-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50261-313-01 [50261031301]

ANNOVERA RING

• Marketing Category: NDA
• Application Number: NDA209627
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-12

Drug Details

Active Ingredients

Ingredient	Strength
SEGESTERONE ACETATE	103 mg/1

OpenFDA Data

• SPL SET ID: 37bb9ebd-2e99-4453-bbe6-9dd4a2897193
• Manufacturer:
  • TherapeuticsMD, Inc.
• UNII:
  • 9AMX4Q13CC
  • 423D2T571U

Pharmacological Class

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

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

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