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FDA Drug information

Omeprazole

Read time: 1 mins
Marketing start date: 26 Nov 2024
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Summary of product characteristics


Effective Time

20230927

Version

9

Spl Product Data Elements

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

Application Number

ANDA091352

Brand Name

Omeprazole

Generic Name

Omeprazole

Product Ndc

65841-761

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

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

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