estradiol

Generic: estradiol

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name estradiol
Generic Name estradiol
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol 2 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-702
Product ID 54348-702_ea93984c-32fa-71e9-e053-2995a90a84d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040197
Listing Expiration 2026-12-31
Marketing Start 2019-07-09

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 54348702
Hyphenated Format 54348-702

Supplemental Identifiers

RxCUI
197659
UNII
4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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 ANDA040197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-702-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (1)

54348-702-90 1 BOTTLE in 1 BOX (54348-702-90) / 90 TABLET in 1 BOTTLE

Ingredients (1)

estradiol (2 mg/1)

Linked Drug Pages (1)

Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea93984c-32fa-71e9-e053-2995a90a84d2", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197659"], "spl_set_id": ["8f8c5a0b-4d7b-a5cb-e053-2995a90a494e"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-702-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "54348-702-90", "marketing_start_date": "20190709"}], "brand_name": "Estradiol", "product_id": "54348-702_ea93984c-32fa-71e9-e053-2995a90a84d2", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "54348-702", "generic_name": "ESTRADIOL", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "2 mg/1"}], "application_number": "ANDA040197", "marketing_category": "ANDA", "marketing_start_date": "20190709", "listing_expiration_date": "20261231"}