NDC 63539-122

Duavee

Conjugated Estrogens/bazedoxifene

Duavee is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Estrogens, Conjugated; Bazedoxifene Acetate.

• Product ID: 63539-122_1ffdfead-c29d-4c8d-9720-a6e89c7a0979
• NDC: 63539-122
• Product Type: Human Prescription Drug
• Proprietary Name: Duavee
• Generic Name: Conjugated Estrogens/bazedoxifene
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-11-15
• Marketing Category: NDA / NDA
• Application Number: NDA022247
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE
• Active Ingredient Strength: 0 mg/1; mg/1
• Pharm Classes: Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63539-122-07

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

• Marketing Start Date: 2013-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63539-122-07 [63539012207]

Duavee TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022247
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-15

Drug Details

Active Ingredients

Ingredient	Strength
ESTROGENS, CONJUGATED	.45 mg/1

OpenFDA Data

• SPL SET ID: e16705d8-4472-4f83-96ac-69fa2be066cb
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • IU5QR144QX
  • J70472UD3D
• RxNorm Concept Unique ID - RxCUI:
  • 1441740
  • 1441392

Pharmacological Class

• Estrogen [EPC]
• Estrogen Receptor Agonists [MoA]
• Estrogens
• Conjugated (USP) [CS]
• Estrogen Agonist/Antagonist [EPC]
• Selective Estrogen Receptor Modulators [MoA]

NDC Crossover Matching brand name "Duavee" or generic name "Conjugated Estrogens/bazedoxifene"

NDC	Brand Name	Generic Name
0008-1123	Duavee	conjugated estrogens/bazedoxifene
63539-112	Duavee	conjugated estrogens/bazedoxifene
63539-122	Duavee	conjugated estrogens/bazedoxifene