lyllana

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol .0375 mg/d

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-148
Product ID 65162-148_6828b547-27f6-4099-981f-a8efcba66370
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211396
Listing Expiration 2026-12-31
Marketing Start 2020-09-30

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 65162148
Hyphenated Format 65162-148

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632 2399892 2399895 2399898 2399901 2399904
UPC
0365162126082 0365162150087 0365162148084 0365162228083 0365162149081
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 lyllana (source: ndc)
Generic Name estradiol (source: ndc)
Application Number ANDA211396 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .0375 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 CARTON (65162-148-08) / 1 d in 1 POUCH (65162-148-04)
source: ndc

Packages (1)

65162-148-08 8 POUCH in 1 CARTON (65162-148-08) / 1 d in 1 POUCH (65162-148-04)

Ingredients (1)

estradiol (.0375 mg/d)

Linked Drug Pages (1)

LYLLANA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "6828b547-27f6-4099-981f-a8efcba66370", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0365162126082", "0365162150087", "0365162148084", "0365162228083", "0365162149081"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632", "2399892", "2399895", "2399898", "2399901", "2399904"], "spl_set_id": ["09c472c6-a38a-4a3d-b048-6fefd52e2ad3"], "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 (65162-148-08)  / 1 d in 1 POUCH (65162-148-04)", "package_ndc": "65162-148-08", "marketing_start_date": "20200930"}], "brand_name": "LYLLANA", "product_id": "65162-148_6828b547-27f6-4099-981f-a8efcba66370", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "65162-148", "generic_name": "Estradiol", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYLLANA", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".0375 mg/d"}], "application_number": "ANDA211396", "marketing_category": "ANDA", "marketing_start_date": "20200930", "listing_expiration_date": "20261231"}