estradiol

Generic: estradiol

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler zydus lifesciences limited
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

estradiol .014 mg/d

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1400
Product ID 70771-1400_7287c5b3-80de-4eab-9905-f597a4fbaf34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204379
Listing Expiration 2026-12-31
Marketing Start 2023-11-02

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 707711400
Hyphenated Format 70771-1400

Supplemental Identifiers

RxCUI
476545
UPC
0370771140046
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 ANDA204379 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .014 mg/d
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (70771-1400-4) / 1 PATCH in 1 POUCH (70771-1400-1) / 7 d in 1 PATCH
source: ndc

Packages (1)

70771-1400-4 4 POUCH in 1 CARTON (70771-1400-4) / 1 PATCH in 1 POUCH (70771-1400-1) / 7 d in 1 PATCH

Ingredients (1)

estradiol (.014 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": "7287c5b3-80de-4eab-9905-f597a4fbaf34", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0370771140046"], "unii": ["4TI98Z838E"], "rxcui": ["476545"], "spl_set_id": ["2f2030c2-f72e-4142-9cff-540bc8fbf8a1"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (70771-1400-4)  / 1 PATCH in 1 POUCH (70771-1400-1)  / 7 d in 1 PATCH", "package_ndc": "70771-1400-4", "marketing_start_date": "20231102"}], "brand_name": "estradiol", "product_id": "70771-1400_7287c5b3-80de-4eab-9905-f597a4fbaf34", "dosage_form": "PATCH", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "70771-1400", "generic_name": "estradiol", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".014 mg/d"}], "application_number": "ANDA204379", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}