Omeprazole Delayed-release Capsules, Usp

SPL v11

SPL

SPL Set ID 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2

Route

ORAL

Published

Effective Date 2024-07-29

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Omeprazole (10 mg)

Inactive Ingredients

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 Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: ZA;11;40mg Shape: capsule Color: purple Color: white Color: brown Size: 10 mm Size: 11 mm Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2012-11-23

Description

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

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-759-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 10 mg

R_xonly

100 Capsules

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

R_xonly

100 Capsules

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

R_xonly

100 Capsules

Structured Label Content

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_xonly

100 Capsules

NDC 65841-760-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 20 mg

R_xonly

100 Capsules

NDC 65841-761-01 in bottle of 100 Capsules

Omeprazole Delayed-release Capsules USP, 40 mg

R_xonly

100 Capsules

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE", "unii": "94255I6E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", 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Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:01.382649 · Updated: 2026-03-14T22:18:26.158923