estradiol

Generic: estradiol

Labeler: noven therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler noven therapeutics, llc
Dosage Form FILM, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .0375 mg/d

Manufacturer
Noven Therapeutics, LLC

Identifiers & Regulatory

Product NDC 68968-3437
Product ID 68968-3437_4d2e5c5f-d82f-4a2c-bfa5-2899fb283696
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203752
Listing Expiration 2026-12-31
Marketing Start 2018-01-01

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 689683437
Hyphenated Format 68968-3437

Supplemental Identifiers

RxCUI
241946 242891 242892 248478 1149632
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 NDA203752 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .0375 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 CARTON (68968-3437-8) / 1 d in 1 POUCH
source: ndc

Packages (1)

68968-3437-8 8 POUCH in 1 CARTON (68968-3437-8) / 1 d in 1 POUCH

Ingredients (1)

estradiol (.0375 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": "4d2e5c5f-d82f-4a2c-bfa5-2899fb283696", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["241946", "242891", "242892", "248478", "1149632"], "spl_set_id": ["bf185599-2138-4083-9c52-2b95dce09ae0"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Noven Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 CARTON (68968-3437-8)  / 1 d in 1 POUCH", "package_ndc": "68968-3437-8", "marketing_start_date": "20180101"}], "brand_name": "Estradiol", "product_id": "68968-3437_4d2e5c5f-d82f-4a2c-bfa5-2899fb283696", "dosage_form": "FILM, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68968-3437", "generic_name": "estradiol", "labeler_name": "Noven Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".0375 mg/d"}], "application_number": "NDA203752", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}