estradiol vaginal

Generic: estradiol

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol vaginal
Generic Name estradiol
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

estradiol hemihydrate .1 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-085
Product ID 21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209767
Listing Expiration 2026-12-31
Marketing Start 2025-08-14

Pharmacologic Class

Classes
estradiol congeners [cs] estrogen receptor agonists [moa] estrogen [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922085
Hyphenated Format 21922-085

Supplemental Identifiers

RxCUI
310169
UPC
0321922085068
UNII
CXY7B3Q98Z

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 estradiol vaginal (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA209767 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

21922-085-06 1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE

Ingredients (1)

estradiol hemihydrate (.1 mg/g)

Linked Drug Pages (1)

ESTRADIOL VAGINAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "1c61e837-4196-4b4d-9545-96b2d7c66f13", "openfda": {"upc": ["0321922085068"], "unii": ["CXY7B3Q98Z"], "rxcui": ["310169"], "spl_set_id": ["1c61e837-4196-4b4d-9545-96b2d7c66f13"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-085-06)  / 42.5 g in 1 TUBE", "package_ndc": "21922-085-06", "marketing_start_date": "20250814"}], "brand_name": "ESTRADIOL VAGINAL", "product_id": "21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13", "dosage_form": "CREAM", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "21922-085", "generic_name": "Estradiol", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTRADIOL VAGINAL", "active_ingredients": [{"name": "ESTRADIOL HEMIHYDRATE", "strength": ".1 mg/g"}], "application_number": "ANDA209767", "marketing_category": "ANDA", "marketing_start_date": "20250814", "listing_expiration_date": "20261231"}