dotti

Generic: estradiol

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dotti
Generic Name estradiol
Labeler amneal pharmaceuticals llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .05 mg/d

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-993
Product ID 65162-993_d26f45d5-79c5-429a-bb0f-44c58fa0b569
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211293
Listing Expiration 2026-12-31
Marketing Start 2019-02-04

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 65162993
Hyphenated Format 65162-993

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632 2110774 2110777 2110780 2110783 2110786
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 dotti (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA211293 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 CARTON (65162-993-08) / 1 d in 1 POUCH (65162-993-04)
source: ndc

Packages (1)

65162-993-08 8 POUCH in 1 CARTON (65162-993-08) / 1 d in 1 POUCH (65162-993-04)

Ingredients (1)

estradiol (.05 mg/d)

Linked Drug Pages (1)

DOTTI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "d26f45d5-79c5-429a-bb0f-44c58fa0b569", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632", "2110774", "2110777", "2110780", "2110783", "2110786"], "spl_set_id": ["53016d30-6b5f-49da-ac16-85ef415a5805"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 CARTON (65162-993-08)  / 1 d in 1 POUCH (65162-993-04)", "package_ndc": "65162-993-08", "marketing_start_date": "20190204"}], "brand_name": "DOTTI", "product_id": "65162-993_d26f45d5-79c5-429a-bb0f-44c58fa0b569", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "65162-993", "generic_name": "Estradiol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOTTI", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".05 mg/d"}], "application_number": "ANDA211293", "marketing_category": "ANDA", "marketing_start_date": "20190204", "listing_expiration_date": "20261231"}