imvexxy

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol 4 ug/1

Manufacturer
Mayne Pharma LLC

Identifiers & Regulatory

Product NDC 50261-104
Product ID 50261-104_3ef13c12-867e-6b00-e063-6394a90abaa3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208564
Listing Expiration 2026-12-31
Marketing Start 2018-07-05

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 50261104
Hyphenated Format 50261-104

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
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strengths. IMVEXXY (estradiol vaginal inserts), 4 mcg and 10 mcg, are provided in opaque push- through blisters and are packaged in cartons containing either 18 inserts for the starter pack or 8 inserts for the maintenance pack. IMVEXXY 4 mcg 8 inserts NDC 50261-104-08 IMVEXXY 4 mcg 18 inserts NDC 50261-104-18 IMVEXXY 10 mcg 8 inserts NDC 50261-110-08 IMVEXXY 10 mcg 18 inserts NDC 50261-110-18 Keep out of reach of children. Packages are not child-resistant. 16.2 Storage and Handling Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.]
  • Principal Display Panel - Imvexxy 4 mcg 8 Count Carton Label NDC 50261-104-08 Rx only Imvexxy ® 4 mcg (estradiol vaginal inserts) TherapeuticsMD ® 8 vaginal inserts FOR VAGINAL USE ONLY Principal Display Panel - Imvexxy 4 mcg 8 Count Carton Label
  • Principal Display Panel - Imvexxy 4 mcg 18 Count Carton Label NDC 50261-104-18 Rx only Imvexxy ® 4 mcg (estradiol vaginal inserts) TherapeuticsMD ® 18 vaginal inserts FOR VAGINAL USE ONLY Principal Display Panel - Imvexxy 4 mcg 18 Count Carton Label
  • Principal Display Panel - Imvexxy 10 mcg 8 Count Carton Label NDC 50261-110-08 Rx only Imvexxy ® 10 mcg (estradiol vaginal inserts) TherapeuticsMD ® 8 vaginal inserts FOR VAGINAL USE ONLY Principal Display Panel - Imvexxy 10 mcg 8 Count Carton Label
  • Principal Display Panel - Imvexxy 10 mcg 18 Count Carton Label NDC 50261-110-18 Rx only Imvexxy ® 10 mcg (estradiol vaginal inserts) TherapeuticsMD ® 18 vaginal inserts FOR VAGINAL USE ONLY Principal Display Panel - Imvexxy 10 mcg 18 Count Carton Label
source: label

Packages (0)

No package records.

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": "3ef13c12-867e-6b00-e063-6394a90abaa3", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["884707", "2048916", "2048917", "2048918", "2054309", "2054310", "2054312", "2054313", "2054315", "2054316", "2054317", "2054318"], "spl_set_id": ["104be9f2-a8f6-430e-9e01-2ee7cc1861f1"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Mayne Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "IMVEXXY", "product_id": "50261-104_3ef13c12-867e-6b00-e063-6394a90abaa3", "dosage_form": "INSERT", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "50261-104", "generic_name": "estradiol", "labeler_name": "Mayne Pharma LLC", "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": "20180705", "listing_expiration_date": "20261231"}