estradiol

Generic: estradiol gel 0.1%

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol gel 0.1%
Labeler xiromed, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol .25 mg/.25g

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-143
Product ID 70700-143_6bb1aab9-ed96-51da-0e8a-b87af5450fdd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211783
Listing Expiration 2027-12-31
Marketing Start 2022-10-01

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 70700143
Hyphenated Format 70700-143

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 (source: ndc)
Generic Name estradiol gel 0.1% (source: ndc)
Application Number ANDA211783 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/.25g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (70700-143-35) / .25 g in 1 PACKET
source: ndc

Packages (1)

70700-143-35 30 PACKET in 1 CARTON (70700-143-35) / .25 g in 1 PACKET

Ingredients (1)

estradiol (.25 mg/.25g)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6bb1aab9-ed96-51da-0e8a-b87af5450fdd", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619679", "2619681", "2619683", "2619685"], "spl_set_id": ["1a46efe6-21b9-3f0f-90b9-59f279ef51df"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (70700-143-35)  / .25 g in 1 PACKET", "package_ndc": "70700-143-35", "marketing_start_date": "20221001"}], "brand_name": "Estradiol", "product_id": "70700-143_6bb1aab9-ed96-51da-0e8a-b87af5450fdd", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "70700-143", "generic_name": "Estradiol Gel 0.1%", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".25 mg/.25g"}], "application_number": "ANDA211783", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20271231"}