NDC 58604-214

ADDYI

Flibanserin

ADDYI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sprout Pharmaceuticals, Inc.. The primary component is Flibanserin.

• Product ID: 58604-214_3ea4dab6-f67d-bc31-88a2-f2f4fdda182b
• NDC: 58604-214
• Product Type: Human Prescription Drug
• Proprietary Name: ADDYI
• Generic Name: Flibanserin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-18
• Marketing Category: NDA / NDA
• Application Number: NDA022526
• Labeler Name: Sprout Pharmaceuticals, Inc.
• Substance Name: FLIBANSERIN
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58604-214-30

1 BOTTLE in 1 CARTON (58604-214-30) > 30 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2015-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58604-214-30 [58604021430]

ADDYI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022526
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-18

NDC 58604-214-03 [58604021403]

ADDYI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022526
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-18
• Marketing End Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
FLIBANSERIN	100 mg/1

OpenFDA Data

• SPL SET ID: 3819daf3-e935-2c53-c527-e1d57922f394
• Manufacturer:
  • Sprout Pharmaceuticals, Inc.
• UNII:
  • 37JK4STR6Z
• RxNorm Concept Unique ID - RxCUI:
  • 1666391
  • 1665514

Pharmacological Class

• P-Glycoprotein Inhibitors [MoA]