duavee

Generic: conjugated estrogens/bazedoxifene

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name duavee
Generic Name conjugated estrogens/bazedoxifene
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bazedoxifene acetate 20 mg/1, estrogens, conjugated .45 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-122
Product ID 63539-122_942e74ec-8c54-444a-9502-89c17ff40688
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022247
Listing Expiration 2026-12-31
Marketing Start 2013-11-15

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estrogens, conjugated (usp) [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539122
Hyphenated Format 63539-122

Supplemental Identifiers

RxCUI
1441392 1441740
UNII
J70472UD3D IU5QR144QX
NUI
N0000175825 N0000000100 M0007792

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 duavee (source: ndc)
Generic Name conjugated estrogens/bazedoxifene (source: ndc)
Application Number NDA022247 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • .45 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

63539-122-07 1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

bazedoxifene acetate (20 mg/1) estrogens, conjugated (.45 mg/1)

Linked Drug Pages (1)

Duavee ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "942e74ec-8c54-444a-9502-89c17ff40688", "openfda": {"nui": ["N0000175825", "N0000000100", "M0007792"], "unii": ["J70472UD3D", "IU5QR144QX"], "rxcui": ["1441392", "1441740"], "spl_set_id": ["e16705d8-4472-4f83-96ac-69fa2be066cb"], "pharm_class_cs": ["Estrogens, Conjugated (USP) [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (63539-122-07)  / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63539-122-07", "marketing_start_date": "20131115"}], "brand_name": "Duavee", "product_id": "63539-122_942e74ec-8c54-444a-9502-89c17ff40688", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Estrogens", "Conjugated (USP) [CS]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "63539-122", "generic_name": "conjugated estrogens/bazedoxifene", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duavee", "active_ingredients": [{"name": "BAZEDOXIFENE ACETATE", "strength": "20 mg/1"}, {"name": "ESTROGENS, CONJUGATED", "strength": ".45 mg/1"}], "application_number": "NDA022247", "marketing_category": "NDA", "marketing_start_date": "20131115", "listing_expiration_date": "20261231"}