estrogel

Generic: estradiol

Labeler: ascend therapeutics us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name estrogel
Generic Name estradiol
Labeler ascend therapeutics us, llc
Dosage Form GEL, METERED
Routes
TOPICAL
Active Ingredients

estradiol .75 mg/1.25g

Manufacturer
ASCEND Therapeutics US, LLC

Identifiers & Regulatory

Product NDC 17139-617
Product ID 17139-617_54aba238-e71b-4933-a9ca-5fcaa6b8183a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021166
Listing Expiration 2027-12-31
Marketing Start 2004-02-09

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 17139617
Hyphenated Format 17139-617

Supplemental Identifiers

RxCUI
226597 581549
UPC
0317139617406
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 estrogel (source: ndc)
Generic Name estradiol (source: ndc)
Application Number NDA021166 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1.25g
source: ndc
Packaging
  • 50 g in 1 BOTTLE, PUMP (17139-617-40)
source: ndc

Packages (1)

17139-617-40 50 g in 1 BOTTLE, PUMP (17139-617-40)

Ingredients (1)

estradiol (.75 mg/1.25g)

Linked Drug Pages (1)

EstroGel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "54aba238-e71b-4933-a9ca-5fcaa6b8183a", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0317139617406"], "unii": ["4TI98Z838E"], "rxcui": ["226597", "581549"], "spl_set_id": ["762ac371-bb8b-47e7-b48f-e80d452c9dd4"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["ASCEND Therapeutics US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 g in 1 BOTTLE, PUMP (17139-617-40)", "package_ndc": "17139-617-40", "marketing_start_date": "20040209"}], "brand_name": "EstroGel", "product_id": "17139-617_54aba238-e71b-4933-a9ca-5fcaa6b8183a", "dosage_form": "GEL, METERED", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "17139-617", "generic_name": "estradiol", "labeler_name": "ASCEND Therapeutics US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EstroGel", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".75 mg/1.25g"}], "application_number": "NDA021166", "marketing_category": "NDA", "marketing_start_date": "20040209", "listing_expiration_date": "20271231"}