estradiol gel

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name estradiol gel
Generic Name estradiol
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol .75 mg/.75g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-088
Product ID 21922-088_42e945c1-4b23-4565-947b-968ef270ea28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218507
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

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 21922088
Hyphenated Format 21922-088

Supplemental Identifiers

RxCUI
2619677 2619679 2619681 2619683 2619685
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 estradiol gel (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA218507 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/.75g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (21922-088-52) / .75 g in 1 PACKET
source: ndc

Packages (1)

21922-088-52 30 PACKET in 1 CARTON (21922-088-52) / .75 g in 1 PACKET

Ingredients (1)

estradiol (.75 mg/.75g)

Linked Drug Pages (1)

Estradiol Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42e945c1-4b23-4565-947b-968ef270ea28", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619679", "2619681", "2619683", "2619685"], "spl_set_id": ["d4a3606f-83b2-45df-bc77-faebfa796f9a"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (21922-088-52)  / .75 g in 1 PACKET", "package_ndc": "21922-088-52", "marketing_start_date": "20250310"}], "brand_name": "Estradiol Gel", "product_id": "21922-088_42e945c1-4b23-4565-947b-968ef270ea28", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "21922-088", "generic_name": "Estradiol", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol Gel", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".75 mg/.75g"}], "application_number": "ANDA218507", "marketing_category": "ANDA", "marketing_start_date": "20250310", "listing_expiration_date": "20261231"}