estradiol

Generic: estradiol

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler zydus pharmaceuticals usa inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .05 mg/d

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1193
Product ID 70710-1193_51a2adf6-a381-42cb-bf3e-8c83a7cfe738
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206241
Listing Expiration 2026-12-31
Marketing Start 2023-04-13

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 707101193
Hyphenated Format 70710-1193

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632
UPC
0370710119188 0370710119485 0370710119287
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 ANDA206241 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 BOX (70710-1193-8) / 1 PATCH in 1 POUCH (70710-1193-1) / 3.5 d in 1 PATCH
source: ndc

Packages (1)

70710-1193-8 8 POUCH in 1 BOX (70710-1193-8) / 1 PATCH in 1 POUCH (70710-1193-1) / 3.5 d in 1 PATCH

Ingredients (1)

estradiol (.05 mg/d)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "51a2adf6-a381-42cb-bf3e-8c83a7cfe738", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0370710119188", "0370710119485", "0370710119287"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632"], "spl_set_id": ["839fe7ae-6835-4d6a-b6b1-ca7f062caa4f"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 BOX (70710-1193-8)  / 1 PATCH in 1 POUCH (70710-1193-1)  / 3.5 d in 1 PATCH", "package_ndc": "70710-1193-8", "marketing_start_date": "20230413"}], "brand_name": "Estradiol", "product_id": "70710-1193_51a2adf6-a381-42cb-bf3e-8c83a7cfe738", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "70710-1193", "generic_name": "Estradiol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".05 mg/d"}], "application_number": "ANDA206241", "marketing_category": "ANDA", "marketing_start_date": "20230413", "listing_expiration_date": "20261231"}