estradiol

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol .5 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8626
Product ID 68788-8626_b11ed340-4c03-41f8-b040-33dcad5f0ec1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217334
Listing Expiration 2026-12-31
Marketing Start 2024-04-09

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 687888626
Hyphenated Format 68788-8626

Supplemental Identifiers

RxCUI
197657
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 ANDA217334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8626-1)
  • 30 TABLET in 1 BOTTLE (68788-8626-3)
  • 60 TABLET in 1 BOTTLE (68788-8626-6)
  • 90 TABLET in 1 BOTTLE (68788-8626-9)
source: ndc

Packages (4)

68788-8626-1 100 TABLET in 1 BOTTLE (68788-8626-1) 68788-8626-3 30 TABLET in 1 BOTTLE (68788-8626-3) 68788-8626-6 60 TABLET in 1 BOTTLE (68788-8626-6) 68788-8626-9 90 TABLET in 1 BOTTLE (68788-8626-9)

Ingredients (1)

estradiol (.5 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": "b11ed340-4c03-41f8-b040-33dcad5f0ec1", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197657"], "spl_set_id": ["6d129a94-8ecd-40a3-9a95-c5e1ece41ab1"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8626-1)", "package_ndc": "68788-8626-1", "marketing_start_date": "20240409"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8626-3)", "package_ndc": "68788-8626-3", "marketing_start_date": "20240409"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8626-6)", "package_ndc": "68788-8626-6", "marketing_start_date": "20240409"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8626-9)", "package_ndc": "68788-8626-9", "marketing_start_date": "20240409"}], "brand_name": "Estradiol", "product_id": "68788-8626_b11ed340-4c03-41f8-b040-33dcad5f0ec1", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "68788-8626", "generic_name": "Estradiol", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}], "application_number": "ANDA217334", "marketing_category": "ANDA", "marketing_start_date": "20240409", "listing_expiration_date": "20261231"}