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Omeprazole - Medication Information

Product NDC Code 65841-760
Drug Name

Omeprazole

Type Generic
Pharm Class Cytochrome P450 2C19 Inhibitors [MoA],
Proton Pump Inhibitor [EPC],
Proton Pump Inhibitors [MoA]
Active Ingredients
Omeprazole 20 mg/1
Route ORAL
Dosage Form CAPSULE, DELAYED RELEASE
RxCUI drug identifier 198051,
199119,
200329
Application Number ANDA091352
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-760-01 100 capsule, delayed release in 1 bottle (65841-760-01)
65841-760-05 500 capsule, delayed release in 1 bottle (65841-760-05)
65841-760-06 30 capsule, delayed release in 1 bottle (65841-760-06)
65841-760-10 1000 capsule, delayed release in 1 bottle (65841-760-10)
65841-760-16 90 capsule, delayed release in 1 bottle (65841-760-16)
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Spl product data elements

Usually a list of ingredients in a drug product.
Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;09;10mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE TAN WHITE CAPSULE ZA;10;20mg Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE ACETONE FD&C BLUE NO. 1 FD&C GREEN NO. 3 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC, DIHYDRATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE AMETHYST PURPLE WHITE CAPSULE ZA;11;40mg

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-759-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 10 mg R x only 100 Capsules NDC 65841-760-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 20 mg R x only 100 Capsules NDC 65841-761-01 in bottle of 100 Capsules Omeprazole Delayed-release Capsules USP, 40 mg R x only 100 Capsules Omeprazole DR Capsules, 10 mg Omeprazole DR Capsules, 20 mg Omeprazole DR Capsules, 40 mg

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API