imvexxy

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name imvexxy
Generic Name estradiol
Labeler mayne pharma
Dosage Form INSERT
Routes
VAGINAL
Active Ingredients

estradiol 4 ug/1

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-747
Product ID 68308-747_6f39160a-1005-43a1-af4c-e9a26e6089ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208564
Listing Expiration 2026-12-31
Marketing Start 2024-05-03

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308747
Hyphenated Format 68308-747

Supplemental Identifiers

RxCUI
884707 2048916 2048917 2048918 2054309 2054310 2054312 2054313 2054315 2054316 2054317 2054318
UNII
4TI98Z838E
NUI
M0447348 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 imvexxy (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA208564 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 4 ug/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68308-747-00) / 2 INSERT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (68308-747-08) / 8 INSERT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (68308-747-18) / 18 INSERT in 1 BLISTER PACK
source: ndc

Packages (3)

68308-747-00 1 BLISTER PACK in 1 CARTON (68308-747-00) / 2 INSERT in 1 BLISTER PACK 68308-747-08 1 BLISTER PACK in 1 CARTON (68308-747-08) / 8 INSERT in 1 BLISTER PACK 68308-747-18 1 BLISTER PACK in 1 CARTON (68308-747-18) / 18 INSERT in 1 BLISTER PACK

Ingredients (1)

estradiol (4 ug/1)

Linked Drug Pages (1)

Imvexxy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "6f39160a-1005-43a1-af4c-e9a26e6089ba", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["884707", "2048916", "2048917", "2048918", "2054309", "2054310", "2054312", "2054313", "2054315", "2054316", "2054317", "2054318"], "spl_set_id": ["6ce645c0-a550-4ae9-8dbd-3853ee8b7d26"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "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 BLISTER PACK in 1 CARTON (68308-747-00)  / 2 INSERT in 1 BLISTER PACK", "package_ndc": "68308-747-00", "marketing_start_date": "20241125"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68308-747-08)  / 8 INSERT in 1 BLISTER PACK", "package_ndc": "68308-747-08", "marketing_start_date": "20240503"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68308-747-18)  / 18 INSERT in 1 BLISTER PACK", "package_ndc": "68308-747-18", "marketing_start_date": "20240603"}], "brand_name": "Imvexxy", "product_id": "68308-747_6f39160a-1005-43a1-af4c-e9a26e6089ba", "dosage_form": "INSERT", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68308-747", "generic_name": "estradiol", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imvexxy", "active_ingredients": [{"name": "ESTRADIOL", "strength": "4 ug/1"}], "application_number": "NDA208564", "marketing_category": "NDA", "marketing_start_date": "20240503", "listing_expiration_date": "20261231"}