osphena

Generic: ospemifene

Labeler: duchesnay usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name osphena
Generic Name ospemifene
Labeler duchesnay usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ospemifene 60 mg/1

Manufacturer
Duchesnay USA, Inc.

Identifiers & Regulatory

Product NDC 55494-580
Product ID 55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203505
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

Pharmacologic Class

Established (EPC)
estrogen agonist/antagonist [epc]
Mechanism of Action
selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55494580
Hyphenated Format 55494-580

Supplemental Identifiers

RxCUI
1370976 1370982
UNII
B0P231ILBK
NUI
N0000175826 N0000000168

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 osphena (source: ndc)
Generic Name ospemifene (source: ndc)
Application Number NDA203505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)
  • 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)
source: ndc

Packages (4)

55494-580-18 1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK 55494-580-30 30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) 55494-580-55 1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK 55494-580-90 90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)

Ingredients (1)

ospemifene (60 mg/1)

Linked Drug Pages (1)

Osphena ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e1f0dd2-9e5b-413e-e063-6294a90a636a", "openfda": {"nui": ["N0000175826", "N0000000168"], "unii": ["B0P231ILBK"], "rxcui": ["1370976", "1370982"], "spl_set_id": ["9accbcc9-78ee-4f84-9b7e-704f2ab1c413"], "pharm_class_epc": ["Estrogen Agonist/Antagonist [EPC]"], "pharm_class_moa": ["Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Duchesnay USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 PACKAGE (55494-580-18)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55494-580-18", "marketing_start_date": "20230401"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)", "package_ndc": "55494-580-30", "marketing_start_date": "20230801"}, {"sample": true, "description": "1 BLISTER PACK in 1 PACKAGE (55494-580-55)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55494-580-55", "marketing_start_date": "20230401"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)", "package_ndc": "55494-580-90", "marketing_start_date": "20230401"}], "brand_name": "Osphena", "product_id": "55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "55494-580", "generic_name": "Ospemifene", "labeler_name": "Duchesnay USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Osphena", "active_ingredients": [{"name": "OSPEMIFENE", "strength": "60 mg/1"}], "application_number": "NDA203505", "marketing_category": "NDA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}