annovera

Generic: segesterone acetate and ethinyl estradiol

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name annovera
Generic Name segesterone acetate and ethinyl estradiol
Labeler mayne pharma
Dosage Form RING
Routes
VAGINAL
Active Ingredients

ethinyl estradiol 17.4 mg/1, segesterone acetate 103 mg/1

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-752
Product ID 68308-752_88f47600-fe7d-4744-be8d-e29dde1711e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209627
Listing Expiration 2026-12-31
Marketing Start 2024-08-16

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308752
Hyphenated Format 68308-752

Supplemental Identifiers

RxCUI
2055983 2055989
UNII
423D2T571U 9AMX4Q13CC
NUI
N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name annovera (source: ndc)
Generic Name segesterone acetate and ethinyl estradiol (source: ndc)
Application Number NDA209627 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 17.4 mg/1
  • 103 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH
source: ndc

Packages (1)

68308-752-01 1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH

Ingredients (2)

ethinyl estradiol (17.4 mg/1) segesterone acetate (103 mg/1)

Linked Drug Pages (1)

Annovera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "88f47600-fe7d-4744-be8d-e29dde1711e5", "openfda": {"nui": ["N0000175825", "N0000000100"], "unii": ["423D2T571U", "9AMX4Q13CC"], "rxcui": ["2055983", "2055989"], "spl_set_id": ["eb18194f-2021-41fa-8bdf-31e0c0eb646b"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (68308-752-01)  / 30 RING in 1 POUCH", "package_ndc": "68308-752-01", "marketing_start_date": "20240816"}], "brand_name": "Annovera", "product_id": "68308-752_88f47600-fe7d-4744-be8d-e29dde1711e5", "dosage_form": "RING", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68308-752", "generic_name": "segesterone acetate and ethinyl estradiol", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Annovera", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "17.4 mg/1"}, {"name": "SEGESTERONE ACETATE", "strength": "103 mg/1"}], "application_number": "NDA209627", "marketing_category": "NDA", "marketing_start_date": "20240816", "listing_expiration_date": "20261231"}