Propafenone ER Capsules, USP

Route
Oral
Dosage form
Extended Release Capsules
Strength
225mg, 325mg, 425mg
Rx/OTC
Rx
Indication
Indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
TE Rating
AB
Reference Listed Drug
Rythmol SR®
ANDA#
212928
Strength Form Product Description Imprint Image How Supplied NDC Number HDMA
Sheets
PI SDS
225mg Extended Release Hard gelatin capsules, No. 1, white opaque cap with white opaque body, the cap is printed with “TWi TO85 225 ” in red ink, containing white to off-white cylindrical-shaped microtablets. TWi TO85 225 Bottle of 60 24979-085-04
325mg Extended Release Hard gelatin capsules, No. 0, white opaque cap with white opaque body, the cap is printed with “TWi TO86 325 ” in red ink, and body is printed with one red band around 3/4 of the circumference of the body, containing white to off-white cylindrical-shaped microtablets. TWi TO86 325 Bottle of 60 24979-086-04
425mg Extended Release Hard gelatin capsules, No. 0EL, white opaque cap with white opaque body, the cap is printed with “TWi TO87 425 ” in red ink, and body is printed with three red bands around 3/4 of the circumference of the body, containing white to off-white cylindrical-shaped microtablets. TWi TO87 425 Bottle of 60 24979-087-04

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