NDC Code(s) : 70771-1668-4, 70771-1668-5
Packager : Zydus Lifesciences Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sildenafil CitrateSildenafil Citrate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1668
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE(UNII: BW9B0ZE037)
(SILDENAFIL - UNII:3M7OB98Y7H) 		SILDENAFIL10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SUCRALOSE(UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
XANTHAN GUM(UNII: TTV12P4NEE)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM BENZOATE(UNII: OJ245FE5EU)
CARBOMER HOMOPOLYMER TYPE A(UNII: F68VH75CJC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70771-1668-41 in 1 CARTON 27/10/2022
1112 mL in 1 BOTTLE, GLASS Type 1: Convenience Kit of Co-Package
2NDC:70771-1668-51 in 1 CARTON 27/10/2022
2112 mL in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215708 10/27/2022

LABELER - Zydus Lifesciences Limited(918596198)

REGISTRANT - Zydus Lifesciences Limited(677605858)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 677605858 ANALYSIS(70771-1668), MANUFACTURE(70771-1668)

PRINCIPAL DISPLAY PANEL

10 mg/mL Amber Glass Bottle Label

NDC 70771-1668-4

Sildenafil for Oral Suspension

10 mg/mL

Shake Well Before Each Use

For Oral Use Only

Zydus

112 mL following Reconstitution

image

PRINCIPAL DISPLAY PANEL - 10 mg/mL Amber Glass Bottle Carton

NDC 70771-1668-4

Sildenafil for Oral Suspension

10 mg/ml

For Oral Use Only

Shake Well Before Each Use

112 mL following Reconstitution

Grape Flavored

Zydus

Rx only

image

10 mg/mL HDPE Bottle Label

NDC 70771-1668-5

Sildenafil for Oral Suspension

10 mg/mL

Shake Well Before Each Use

For Oral Use Only

Zydus

112 mL following Reconstitution

image

PRINCIPAL DISPLAY PANEL - 10 mg/mL HDPE Bottle Carton

NDC 70771-1668-5

Sildenafil for Oral Suspension

10 mg/ml

For Oral Use Only

Shake Well Before Each Use

112 mL following Reconstitution

Grape Flavored

Zydus

Rx only

image