OMEPRAZOLE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

Available from:

Zydus Lifesciences Limited

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Dual Therapy Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility te

Product summary:

Omeprazole Delayed-release Capsules, USP 10 mg are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with amethyst purple- colored cap printed with "ZA-09"in black ink & white body printed with "10 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 65841-759-06 in bottles of 30 capsules NDC 65841-759-16 in bottles of 90 capsules NDC 65841-759-01 in bottles of 100 capsules NDC 65841-759-05 in bottles of 500 capsules NDC 65841-759-10 in bottles of 1000 capsules Omeprazole Delayed-release Capsules, USP 20 mg are white to off-white free flowing pellets filled in size '2' hard gelatin capsules with tan-colored cap printed with "ZA-10"in black ink & white body printed with "20 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 65841-760-06 in bottles of 30 capsules NDC 65841-760-16 in bottles of 90 capsules NDC 65841-760-01 in bottles of 100 capsules NDC 65841-760-05 in bottles of 500 capsules NDC 65841-760-10 in bottles of 1000 capsules Omeprazole Delayed-release Capsules USP, 40 mg are off-white to pale brown free flowing pellets filled in size '1' hard gelatin capsules with amethyst purple colored cap printed with "ZA-11" in black ink & white body printed with "40 mg" in black ink, complies with USP dissolution test 2 and are supplied as follows: NDC 65841-761-06 in bottles of 30 capsules NDC 65841-761-16 in bottles of 90 capsules NDC 65841-761-01 in bottles of 100 capsules NDC 65841-761-05 in bottles of 500 capsules NDC 65841-761-10 in bottles of 1000 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep in a tightly closed container. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 9/2023
Document Id: 02875cb7-9b8a-4452-901d-96ba7004b74d
34391-3
Set id: 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2
Version: 9
Effective Time: 20230927
Zydus Lifesciences Limited

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
ZYDUS LIFESCIENCES LIMITED
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OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-759-01 in bottle of 100 Capsules
Omeprazole Delayed-release Capsules USP, 10 mg
R only
100 Capsules
NDC 65841-760-01 in bottle of 100 Capsules
Omeprazole Delayed-release Capsules USP, 20 mg
R only
100 Capsules
x
x
NDC 65841-761-01 in bottle of 100 Capsules
Omeprazole Delayed-release Capsules USP, 40 mg
R only
100 Capsules
x
OMEPRAZOLE
omeprazole capsule, delayed release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-759
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
OMEPRAZ OLE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ACETONE (UNII: 1364PS73AF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PRODUCT CHARACTERISTICS
COLOR
PURPLE (AMETHYST PURPLE) , WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
10mm
FLAVOR
IMPRINT CODE
Z A;09;10mg
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-759-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
11/23/2012
2
NDC:65841-759-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
11/23/2012
3
NDC:65841-759-
01
100 in 1 BOTT