NDC Code(s) : 69097-527-34
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-527
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CROSPOVIDONE(UNII: 2S7830E561)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
WATER(UNII: 059QF0KO0R)
TALC(UNII: 7SEV7J4R1U)
XANTHAN GUM(UNII: TTV12P4NEE)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-527-3430 in 1 CARTON Type 0: Not a Combination Product24/03/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211752 03/24/2020

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
CIPLA LIMITED 917066446 api manufacture(69097-527), manufacture(69097-527)

Establishment
Name Address ID/FEI Business Operations
CIPLA LIMITED 915154892 analysis(69097-527), api manufacture(69097-527)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 69097-527-34

Esomeprazole Magnesium*

for Delayed-Release Oral Suspension

10 mg

*Each packet Contains: 10.844 mg of

Esomeprazole Magnesium Dihydrate USP

equivalent to Esomeprazole 10 mg (as enteric-coated granules).

Dispense the enclosed Medication Guide to each patient.

Cipla

packet/sachet

Rx Only

NDC 69097-527-34

Esomeprazole Magnesium*

for Delayed-Release Oral Suspension

10 mg

Each carton contains 30 child-resistant packets.

*Each packet Contains: 10.844 mg of Esomeprazole Magnesium Dihydrate USP

equivalent to Esomeprazole 10 mg (as enteric-coated granules).

Dispense the enclosed Medication Guide to each patient.

30 Single Dose Packets

Cipla

packet/sachet