estradiol

Generic: estradiol

Labeler: trigen laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler trigen laboratories, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

estradiol .5 mg/.5g

Manufacturer
Trigen Laboratories, LLC

Identifiers & Regulatory

Product NDC 13811-091
Product ID 13811-091_248c5ced-1972-443a-8cb0-de1e9ab011be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022038
Listing Expiration 2027-12-31
Marketing Start 2022-10-10

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 13811091
Hyphenated Format 13811-091

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 (source: ndc)
Application Number NDA022038 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/.5g
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (13811-091-32) / .5 g in 1 PACKET
source: ndc

Packages (1)

13811-091-32 30 PACKET in 1 CARTON (13811-091-32) / .5 g in 1 PACKET

Ingredients (1)

estradiol (.5 mg/.5g)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "248c5ced-1972-443a-8cb0-de1e9ab011be", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["2619677", "2619679", "2619681", "2619683", "2619685"], "spl_set_id": ["e84ad638-6768-41aa-b2b8-e2514ef63881"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Trigen Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (13811-091-32)  / .5 g in 1 PACKET", "package_ndc": "13811-091-32", "marketing_start_date": "20221010"}], "brand_name": "Estradiol", "product_id": "13811-091_248c5ced-1972-443a-8cb0-de1e9ab011be", "dosage_form": "GEL", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "13811-091", "generic_name": "Estradiol", "labeler_name": "Trigen Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/.5g"}], "application_number": "NDA022038", "marketing_category": "NDA", "marketing_start_date": "20221010", "listing_expiration_date": "20271231"}