estradiol

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol 1 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0886
Product ID 0555-0886_3d020f63-1085-4e6f-9263-2933c29d5e16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040197
Listing Expiration 2026-12-31
Marketing Start 1997-10-28

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 05550886
Hyphenated Format 0555-0886

Supplemental Identifiers

RxCUI
197657 197658 197659
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 ANDA040197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0555-0886-02)
  • 500 TABLET in 1 BOTTLE (0555-0886-04)
source: ndc

Packages (2)

0555-0886-02 100 TABLET in 1 BOTTLE (0555-0886-02) 0555-0886-04 500 TABLET in 1 BOTTLE (0555-0886-04)

Ingredients (1)

estradiol (1 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": "3d020f63-1085-4e6f-9263-2933c29d5e16", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["4TI98Z838E"], "rxcui": ["197657", "197658", "197659"], "spl_set_id": ["c4936878-1643-4e7f-9b0d-e4957935aef2"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0555-0886-02)", "package_ndc": "0555-0886-02", "marketing_start_date": "19971028"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0555-0886-04)", "package_ndc": "0555-0886-04", "marketing_start_date": "19971028"}], "brand_name": "Estradiol", "product_id": "0555-0886_3d020f63-1085-4e6f-9263-2933c29d5e16", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "0555-0886", "generic_name": "Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "1 mg/1"}], "application_number": "ANDA040197", "marketing_category": "ANDA", "marketing_start_date": "19971028", "listing_expiration_date": "20261231"}