estradiol

Generic: estradiol

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

Drug Facts

Product Profile

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

estradiol 2 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-566
Product ID 70954-566_6b381113-0e63-42e0-aeb7-d339e798f444
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217334
Listing Expiration 2026-12-31
Marketing Start 2023-09-06

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 70954566
Hyphenated Format 70954-566

Supplemental Identifiers

RxCUI
197657 197658 197659
UPC
0370954565208 0370954566106 0370954566205 0370954564102 0370954565109
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 ANDA217334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-566-10)
  • 500 TABLET in 1 BOTTLE (70954-566-20)
source: ndc

Packages (2)

70954-566-10 100 TABLET in 1 BOTTLE (70954-566-10) 70954-566-20 500 TABLET in 1 BOTTLE (70954-566-20)

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": "6b381113-0e63-42e0-aeb7-d339e798f444", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "upc": ["0370954565208", "0370954566106", "0370954566205", "0370954564102", "0370954565109"], "unii": ["4TI98Z838E"], "rxcui": ["197657", "197658", "197659"], "spl_set_id": ["3fe899db-a8cd-4a31-88fb-1129be96b4d9"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-566-10)", "package_ndc": "70954-566-10", "marketing_start_date": "20230906"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-566-20)", "package_ndc": "70954-566-20", "marketing_start_date": "20230906"}], "brand_name": "Estradiol", "product_id": "70954-566_6b381113-0e63-42e0-aeb7-d339e798f444", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]"], "product_ndc": "70954-566", "generic_name": "Estradiol", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Estradiol", "active_ingredients": [{"name": "ESTRADIOL", "strength": "2 mg/1"}], "application_number": "ANDA217334", "marketing_category": "ANDA", "marketing_start_date": "20230906", "listing_expiration_date": "20261231"}