estradiol

Generic: estradiol

Labeler: solaris pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler solaris pharma corporation
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol .75 mg/1.25g

Manufacturer
Solaris Pharma Corporation

Identifiers & Regulatory

Product NDC 73473-308
Product ID 73473-308_83acb69b-859c-47f7-9e4b-fe349d0e0aa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216160
Listing Expiration 2027-12-31
Marketing Start 2026-01-28

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 73473308
Hyphenated Format 73473-308

Supplemental Identifiers

RxCUI
226597
UPC
0373473308509
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 (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA216160 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/1.25g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (73473-308-50) / 50 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

Ingredients (1)

estradiol (.75 mg/1.25g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "83acb69b-859c-47f7-9e4b-fe349d0e0aa6", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0373473308509"], "unii": ["4TI98Z838E"], "rxcui": ["226597"], "spl_set_id": ["67e8665c-5331-423c-99fd-546ab6cccb07"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Solaris Pharma Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (73473-308-50)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "73473-308-50", "marketing_start_date": "20260128"}], "brand_name": "Estradiol", "product_id": "73473-308_83acb69b-859c-47f7-9e4b-fe349d0e0aa6", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "73473-308", "generic_name": "Estradiol", "labeler_name": "Solaris Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".75 mg/1.25g"}], "application_number": "ANDA216160", "marketing_category": "ANDA", "marketing_start_date": "20260128", "listing_expiration_date": "20271231"}