Omeprazole 20 mg/1
Omeprazole · CAPSULE, DELAYED RELEASE · Preferred Pharmaceuticals Inc.
Omeprazole is a proton pump inhibitor capsule taken by mouth that reduces stomach acid and is used to treat conditions like acid reflux, heartburn, and ulcers. This prescription medication comes as a delayed-release capsule in 20 mg strength to help protect your stomach lining.
Key Facts
- Brand Name
- Omeprazole
- Generic Name
- Omeprazole
- NDC Code (Product)
68788-8805- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 20 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA078490
- Drug Class
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
- Marketing Start
- 01/20/2025
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.
Dr. Reddy's Laboratories, Inc.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
CutisPharma, Inc.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Breckenridge Pharmaceutical, Inc
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.
Duren Health Mart Pharmacy
Lack of Processing Controls.
CutisPharma, Inc.
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Golden State Medical Supply Inc.
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Dosage & Administration
Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
Warnings
Warnings Allergy alert: do not use if you are allergic to omeprazole omeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednes frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have : had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask doctor if: your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant o…
Frequently Asked Questions
What is Omeprazole used for?
Omeprazole is a proton pump inhibitor capsule taken by mouth that reduces stomach acid and is used to treat conditions like acid reflux, heartburn, and ulcers. This prescription medication comes as a delayed-release capsule in 20 mg strength to help protect your stomach lining.
Is Omeprazole a controlled substance?
Omeprazole is not classified as a controlled substance by the DEA.
What is the generic name for Omeprazole?
The generic name for Omeprazole is Omeprazole. There are 8 other brand versions of Omeprazole.
What is the NDC code for Omeprazole 20 mg/1?
The NDC (National Drug Code) for Omeprazole 20 mg/1 is 68788-8805, listed by Preferred Pharmaceuticals Inc..