ADDYI (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — Carton Label

Rx only
NDC 58604-214-30
addyi®
(flibanserin) tablets
100 mg
Attention Pharmacist: Dispense in original packaging. Dispense the accompanying Medication Guide to each patient. 30 Tablets

Addyi Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Carton Label (New)

Addyi Carton (New)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Bottle Label

Rx only
NDC 58604-214-30
addyi®
(flibanserin) tablets
100 mg
Attention Pharmacist: Dispense in original packaging. Dispense the accompanying Medication Guide to each patient. 30 Tablets

Addyi Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Bottle Label (New)

Addyi Bottle Label (New)
(click image for full-size original)
ADDYI flibanserin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58604-214
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flibanserin (Flibanserin) Flibanserin 100 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate
Microcrystalline Cellulose
Hypromellose, Unspecified
Croscarmellose Sodium
Magnesium Stearate
Talc
Polyethylene Glycol, Unspecified
Titanium Dioxide
Ferric Oxide Red
Product Characteristics
Color PINK Score no score
Shape OVAL Size 14mm
Flavor Imprint Code f100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58604-214-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (58604-214-30)
2 NDC:58604-214-03 1 BOTTLE in 1 CARTON contains a BOTTLE
2 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (58604-214-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022526 08/18/2015
Labeler — Sprout Pharmaceuticals, Inc. (067606232)

Revised: 09/2021 Sprout Pharmaceuticals, Inc.

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