yuvafem

Generic: estradiol

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

Drug Facts

Product Profile

Brand Name yuvafem
Generic Name estradiol
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
VAGINAL
Active Ingredients

estradiol 10 ug/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-226
Product ID 65162-226_b3543f3c-816d-46c4-b9e0-b706d4b1f425
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205256
Listing Expiration 2026-12-31
Marketing Start 2016-10-17

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 65162226
Hyphenated Format 65162-226

Supplemental Identifiers

RxCUI
884707 1797113
UPC
0365162226218
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 yuvafem (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA205256 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 ug/1
source: ndc
Packaging
  • 8 APPLICATOR in 1 CARTON (65162-226-21) / 1 TABLET in 1 APPLICATOR
  • 18 APPLICATOR in 1 CARTON (65162-226-23) / 1 TABLET in 1 APPLICATOR
source: ndc

Packages (2)

65162-226-21 8 APPLICATOR in 1 CARTON (65162-226-21) / 1 TABLET in 1 APPLICATOR 65162-226-23 18 APPLICATOR in 1 CARTON (65162-226-23) / 1 TABLET in 1 APPLICATOR

Ingredients (1)

estradiol (10 ug/1)

Linked Drug Pages (1)

YUVAFEM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "b3543f3c-816d-46c4-b9e0-b706d4b1f425", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0365162226218"], "unii": ["4TI98Z838E"], "rxcui": ["884707", "1797113"], "spl_set_id": ["30c7f6ba-7a9e-4853-b3e4-e00a46560224"], "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 APPLICATOR in 1 CARTON (65162-226-21)  / 1 TABLET in 1 APPLICATOR", "package_ndc": "65162-226-21", "marketing_start_date": "20161017"}, {"sample": false, "description": "18 APPLICATOR in 1 CARTON (65162-226-23)  / 1 TABLET in 1 APPLICATOR", "package_ndc": "65162-226-23", "marketing_start_date": "20161017"}], "brand_name": "YUVAFEM", "product_id": "65162-226_b3543f3c-816d-46c4-b9e0-b706d4b1f425", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "65162-226", "generic_name": "Estradiol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "YUVAFEM", "active_ingredients": [{"name": "ESTRADIOL", "strength": "10 ug/1"}], "application_number": "ANDA205256", "marketing_category": "ANDA", "marketing_start_date": "20161017", "listing_expiration_date": "20261231"}