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
Routes
TRANSDERMAL
Active Ingredients

estradiol .014 mg/d

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-323
Product ID 68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4
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 68382323
Hyphenated Format 68382-323

Supplemental Identifiers

RxCUI
476545
UPC
0368382323040
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 (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH
source: ndc

Packages (1)

68382-323-04 4 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 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": "1e54d575-0530-4304-8a50-3ffaf3c124d4", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0368382323040"], "unii": ["4TI98Z838E"], "rxcui": ["476545"], "spl_set_id": ["684850eb-d889-4370-a0a7-4a5c3113266a"], "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": "4 POUCH in 1 CARTON (68382-323-04)  / 1 PATCH in 1 POUCH (68382-323-01)  / 7 d in 1 PATCH", "package_ndc": "68382-323-04", "marketing_start_date": "20231102"}], "brand_name": "estradiol", "product_id": "68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4", "dosage_form": "PATCH", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68382-323", "generic_name": "estradiol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}