PRILOSEC (Page 13 of 13)

Package/Label Display Panel – 10 mg Capsules

NDC 0186-0606-31

PRILOSEC®

(omeprazole)

30 Delayed-Release Capsules

10 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Prilosec 10 mg 30 Delayed-Release Capsules
(click image for full-size original)

Package/Label Display Panel – 20 mg Capsules

NDC 0186-0742-31

PRILOSEC®

(omeprazole)

30 Delayed-Release Capsules

20 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Prilosec 20 mg 30 Delayed-Release Capsules
(click image for full-size original)

Package/Label Display Panel – 40 mg Capsules

NDC 0186-0743-31

PRILOSEC®

(omeprazole)

30 Delayed-Release Capsules

40 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Prilosec 40 mg 30 Delayed-Release Capsules
(click image for full-size original)

Package/Label Display Panel – 2.5 mg Oral Suspension

NDC 0186-0625-01

PRILOSEC®

(omeprazole magnesium)

For Delayed-Release Oral Suspension

2.5 mg

This packet contains 2.8 mg of omeprazole magnesium which is equivalent

to 2.5 mg of omeprazole as delayed-release granules.

Dispense the enclosed Medication Guide to each patient.

Rx only

Mfd for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca AB, Sodertalje, Sweden

Product of Sweden

AstraZeneca

Prilosec 2 5 mg Delayed-Release Oral Suspension Foil Packet
(click image for full-size original)

Package/Label Display Panel — 10 mg Oral Suspension

NDC 0186-0610-01

PRILOSEC®

(omeprazole magnesium)

For Delayed-Release Oral Suspension

10 mg

This packet contains 11.2 mg of omeprazole magnesium which is equivalent

to 10 mg of omeprazole as delayed-release granules.

Dispense the enclosed Medication Guide to each patient.

Rx only

Mfd for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca AB, Sodertalje, Sweden

Product of Sweden

AstraZeneca

Prilosec 10 mg Delayed-Release Oral Suspension Foil Packet
(click image for full-size original)
PRILOSEC
omeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0606
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MANNITOL
SODIUM LAURYL SULFATE
GELATIN
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C RED NO. 28
TITANIUM DIOXIDE
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
D&C RED NO. 7
D&C YELLOW NO. 10
Product Characteristics
Color PURPLE (apricot and amethyst) Score no score
Shape CAPSULE (opaque, hard gelatin) Size 14mm
Flavor Imprint Code 606;prilosec10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-0606-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:0186-0606-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019810 11/15/1995
PRILOSEC
omeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0742
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
ANHYDROUS LACTOSE
MANNITOL
SODIUM LAURYL SULFATE
GELATIN
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C RED NO. 28
TITANIUM DIOXIDE
BUTYL ALCOHOL
FD&C BLUE NO. 2
D&C RED NO. 7
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
Product Characteristics
Color PURPLE (amethyst) Score no score
Shape CAPSULE (opaque, hard gelatin) Size 17mm
Flavor Imprint Code 742;prilosec20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-0742-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:0186-0742-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019810 10/01/1990
PRILOSEC
omeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0743
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
ANHYDROUS LACTOSE
MANNITOL
SODIUM LAURYL SULFATE
GELATIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
D&C RED NO. 28
D&C YELLOW NO. 10
TITANIUM DIOXIDE
BUTYL ALCOHOL
D&C RED NO. 7
FD&C RED NO. 40
FERROSOFERRIC OXIDE
Product Characteristics
Color PURPLE (apricot and amethyst) Score no score
Shape CAPSULE (opaque, hard gelatin) Size 19mm
Flavor Imprint Code 743;prilosec40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-0743-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:0186-0743-68 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:0186-0743-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019810 06/08/1998
PRILOSEC
omeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0625
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYSORBATE 80
SODIUM HYDROXIDE
TALC
TRIETHYL CITRATE
XANTHAN GUM
ANHYDROUS CITRIC ACID
ANHYDROUS DEXTROSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-0625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022056 02/09/2002
PRILOSEC
omeprazole magnesium granule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
TALC
TRIETHYL CITRATE
ANHYDROUS CITRIC ACID
XANTHAN GUM
ANHYDROUS DEXTROSE
GLYCERYL MONOSTEARATE
METHACRYLIC ACID
POLYSORBATE 80
SODIUM HYDROXIDE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0186-0610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022056 02/09/2002
Labeler — AstraZeneca Pharmaceuticals LP (938368834)
Registrant — AstraZeneca PLC (230790719)

Revised: 12/2016 AstraZeneca Pharmaceuticals LP

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