NDC Code(s) : 67877-571-30, 67877-571-05, 67877-571-10, 67877-571-38, 67877-571-90, 67877-572-30, 67877-572-90, 67877-572-05, 67877-572-10, 67877-572-38
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Esomeprazole magnesium Esomeprazole magnesium delayed release capsules CAPSULE, COATED PELLETS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-571
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
POLOXAMER 188(UNII: LQA7B6G8JG)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code ESOM;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-571-3030 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
2NDC:67877-571-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
3NDC:67877-571-101000 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
4NDC:67877-571-3810 in 1 CARTON 27/02/2021
410 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2021
5NDC:67877-571-9090 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210559 02/27/2021
Esomeprazole magnesium Esomeprazole magnesium delayed release capsules CAPSULE, COATED PELLETS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-572
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9)
(ESOMEPRAZOLE - UNII:N3PA6559FT) 		ESOMEPRAZOLE40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
POLOXAMER 188(UNII: LQA7B6G8JG)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code ESOM;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-572-3030 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
2NDC:67877-572-9090 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
3NDC:67877-572-05500 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
4NDC:67877-572-101000 in 1 BOTTLE Type 0: Not a Combination Product27/02/2021
5NDC:67877-572-3810 in 1 CARTON 27/02/2021
510 in 1 BLISTER PACK Type 0: Not a Combination Product27/02/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210559 02/27/2021

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-571, 67877-572)

PRINCIPAL DISPLAY PANEL

20mg Capsule Bottle Label 

NDC 67877-571-30

30 capsules 

ESOMEPRAZOLE MAGNESIUM delayed-release capsules, USP for oral use

Dispense the accompanying Medication guide to each patient. 

esomeprazole-20mg-30cap

20mg Capsule Bottle Label

NDC 67877-571-90

90 capsules

ESOMEPRAZOLE MAGNESIUM delayed-release capsules, USP for oral use

Dispense the accompanying Medication guide to each patient.

Rx Only

esomeprazole-20mg-30cap


40mg Capsule Bottle Label 

NDC 67877-572-30

30 capsules 

ESOMEPRAZOLE MAGNESIUM delayed-release capsules, USP for oral use

Dispense the accompanying Medication guide to each patient. 

 esomeprazole-20mg-30cap

40mg Capsule Bottle Label

NDC 67877-572-90

90 capsules

ESOMEPRAZOLE MAGNESIUM delayed-release capsules, USP for oral use

Dispense the accompanying Medication guide to each patient.

 esomeprazole-20mg-30cap