Sildenafil: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sildenafil OS 10 mg/mL, Carton

carton-label
(click image for full-size original)
SILDENAFIL sildenafil powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
SODIUM BENZOATE
SORBITOL
SUCRALOSE
TITANIUM DIOXIDE
XANTHAN GUM
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color white (white to off-white powder) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-136-31 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 112 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (31722-136-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213014 05/11/2021
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-136), manufacture (31722-136)

Revised: 05/2023 Camber Pharmaceuticals, Inc.

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