24 HR Diltiazem Hydrochloride 240 MG Extended Release Oral Capsule

INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] off label use` `[2] death` `[3] fatigue` `[4] nausea` `[5] drug ineffective` `[6] pain` `[7] diarrhoea` `[8] arthralgia` `[9] dyspnoea` `[10] headache`

4 years ago

CAPSULE BLUE 597

HOW SUPPLIED

DILTIAZEM HYDROCHLORIDE Extended-release capsules USP, 120 mg are white to off white pellets filled in size "2" empty hard gelatin capsules with opaque light green colored cap & opaque white colored body imprinted with "595" in black ink and are supplied as follows: NDC 68382-595-06 in bottles of 30 capsules with child-resistant closure NDC 68382-595-16 in bottles of 90 capsules with child-resistant closure NDC 68382-595-01 in bottles of 100 capsules NDC 68382-595-05 in bottles of 500 capsules NDC 68382-595-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

DILTIAZEM HYDROCHLORIDE Extended-release capsules USP, 180 mg are white to off white pellets filled in size "0" empty hard gelatin capsules with opaque light blue colored cap & opaque grey colored body imprinted with "596" in black ink and are supplied as follows: NDC 68382-596-06 in bottles of 30 capsules with child-resistant closure NDC 68382-596-16 in bottles of 90 capsules with child-resistant closure NDC 68382-596-01 in bottles of 100 capsules NDC 68382-596-05 in bottles of 500 capsules NDC 68382-596-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

DILTIAZEM HYDROCHLORIDE Extended-release capsules USP, 240 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light blue colored cap & opaque white colored body imprinted with "597" in black ink and are supplied as follows: NDC 68382-597-06 in bottles of 30 capsules with child-resistant closure NDC 68382-597-16 in bottles of 90 capsules with child-resistant closure NDC 68382-597-01 in bottles of 100 capsules NDC 68382-597-05 in bottles of 500 capsules NDC 68382-597-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

DILTIAZEM HYDROCHLORIDE Extended-release capsules USP, 300 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque light green colored cap & opaque grey colored body imprinted with "598" in black ink and are supplied as follows: NDC 68382-598-06 in bottles of 30 capsules with child-resistant closure NDC 68382-598-16 in bottles of 90 capsules with child-resistant closure NDC 68382-598-01 in bottles of 100 capsules NDC 68382-598-05 in bottles of 500 capsules NDC 68382-598-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules

DILTIAZEM HYDROCHLORIDE Extended-release capsules USP, 360 mg are white to off white pellets filled in size "00" empty hard gelatin capsules with opaque grey colored cap & opaque white colored body imprinted with "599" in black ink and are supplied as follows: NDC 68382-599-06 in bottles of 30 capsules with child-resistant closure NDC 68382-599-16 in bottles of 90 capsules with child-resistant closure NDC 68382-599-01 in bottles of 100 capsules NDC 68382-599-05 in bottles of 500 capsules NDC 68382-599-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Avoid excessive humidity. Dispense in a tight container as defined in the USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/22

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