NEXIUM (Page 13 of 13)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg 30 Capsules

NDC 0186-5020-31

NEXIUM^®

(esomeprazole magnesium)

30 Delayed-Release

Capsules

Rx only 20 mg*

Dispense the accompanying

Medication Guide to each patient.

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 40 mg 30 Capsules

NDC 0186-5040-31

NEXIUM^®

(esomeprazole magnesium)

30 Delayed-Release

Capsules

Rx only 40 mg*

Dispense the accompanying

Medication Guide to each patient.

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 2.5 mg Oral Suspension

NDC 0186-4025-01

NEXIUM^®

(esomeprazole magnesium*)

2.5 mg

For Delayed-Release Oral Suspension

Each carton contains 30 child-resistant packets.

*Each packet of delayed release oral suspension contains 2.5 mg of esomeprazole (equivalent to 2.8 mg of esomeprazole magnesium trihydrate).

Dispense the enclosed Medication Guide to each patient.

30 Single Dose Packets

Rx only

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 5 mg Oral Suspension

NDC 0186-4050-01

NEXIUM^®

(esomeprazole magnesium*)

5 mg

For Delayed-Release

Oral Suspension

Each carton contains 30 child-resistant packets.

*Each packet of delayed release oral suspension contains 5 mg of esomeprazole (equivalent to 5.6 mg of esomeprazole magnesium trihydrate).

Dispense the enclosed Medication Guide to each patient.

Rx only

30 Single Dose Packets

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 10 mg Oral Suspension

NDC 0186-4010-01

NEXIUM^®

(esomeprazole magnesium*)

10 mg

For Delayed-Release

Oral Suspension

Each carton contains 30 child-resistant packets.

*Each packet of delayed release oral suspension contains 10 mg of esomeprazole (equivalent to 11.1 mg of esomeprazole magnesium trihydrate).

Dispense the enclosed Medication Guide to each patient.

Rx only

30 Single Dose Packets

AstraZeneca

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg Oral Suspension

NDC 0186-4020-01

NEXIUM^®

(esomeprazole magnesium*)

20 mg

For Delayed-Release

Oral Suspension

Each carton contains 30 child-resistant packets.

*Each packet of delayed release oral suspension contains 20 mg of esomeprazole (equivalent to 22.3 mg of esomeprazole magnesium trihydrate).

Dispense the enclosed Medication Guide to each patient.

Rx only

30 Single Dose Packets

AstraZeneca

Package/Label Display Panel

NDC 0186-4040-01

NEXIUM^®

(esomeprazole magnesium*)

40 mg

For Delayed-Release Oral Suspension

Each carton contains 30 child-resistant packets.

*Each packet of delayed release oral suspension contains 40 mg of esomeprazole (equivalent to 44.5 mg of esomeprazole magnesium trihydrate).

Dispense the enclosed Medication Guide to each patient.

Rx only

30 Single Dose Packets

AstraZeneca

NEXIUM esomeprazole magnesium capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5020 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID TALC TRIETHYL CITRATE POLYSORBATE 80 GELATIN, UNSPECIFIED FD&C BLUE NO. 1 FD&C RED NO. 40 D&C RED NO. 28 TITANIUM DIOXIDE ALCOHOL ISOPROPYL ALCOHOL BUTYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM HYDROXIDE POVIDONE, UNSPECIFIED D&C YELLOW NO. 10

Product Characteristics Color PURPLE (Amethyst) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code NEXIUM20mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-5020-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0186-5020-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 3 NDC:0186-5020-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021153 03/19/2001

NEXIUM esomeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID POTASSIUM SORBATE TALC TRIETHYL CITRATE WATER ANHYDROUS DEXTROSE POVIDONE, UNSPECIFIED ANHYDROUS CITRIC ACID FERRIC OXIDE YELLOW ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-4010-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None 2 NDC:0186-4010-02 5 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022101 07/07/2008

NEXIUM esomeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4020 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID POTASSIUM SORBATE TALC TRIETHYL CITRATE WATER ANHYDROUS DEXTROSE POVIDONE, UNSPECIFIED ANHYDROUS CITRIC ACID FERRIC OXIDE YELLOW ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-4020-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021957 03/19/2007

NEXIUM esomeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4040 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 40 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID POTASSIUM SORBATE TALC TRIETHYL CITRATE WATER ANHYDROUS DEXTROSE POVIDONE, UNSPECIFIED ANHYDROUS CITRIC ACID FERRIC OXIDE YELLOW ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-4040-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None 2 NDC:0186-4040-02 5 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021957 03/19/2007

NEXIUM esomeprazole magnesium capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-5040 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 40 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE METHACRYLIC ACID TALC TRIETHYL CITRATE POLYSORBATE 80 GELATIN, UNSPECIFIED FD&C BLUE NO. 1 FD&C RED NO. 40 D&C RED NO. 28 TITANIUM DIOXIDE ALCOHOL ISOPROPYL ALCOHOL BUTYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM HYDROXIDE POVIDONE, UNSPECIFIED D&C YELLOW NO. 10

Product Characteristics Color PURPLE (Amethyst) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code NEXIUM40mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-5040-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0186-5040-35 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 3 NDC:0186-5040-55 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 4 NDC:0186-5040-85 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 5 NDC:0186-5040-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 6 NDC:0186-5040-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 7 NDC:0186-5040-05 5 CAPSULE, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021153 03/19/2001

NEXIUM esomeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4025 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 2.5 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-4025-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None 2 NDC:0186-4025-02 5 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021957 06/01/2012

NEXIUM esomeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-4050 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 5 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-4050-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021957 06/01/2012

Labeler — AstraZeneca Pharmaceuticals LP (938368834)

Registrant — AstraZeneca PLC (230790719)

Revised: 07/2023 AstraZeneca Pharmaceuticals LP