Topiramate Capsule, Coated Pellets
FDA Label NDC 65841-652

1 label section · Submitted to the FDA by Zydus Lifesciences Limited · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Topiramate (NDC 65841-652). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 65841-651-14 in bottle of 60 capsules

Topiramate Capsules USP, 15 mg

60 capsules

Rx only

Topiramate Capsules (sprinkle), 15 mg (C45924d5 C45b 4f31 Afa5 0cbc090d2816 01)

Topiramate Capsules (sprinkle), 15 mg (C45924d5 C45b 4f31 Afa5 0cbc090d2816 01)

NDC 65841-652-14 in bottle of 60 capsules

Topiramate Capsules USP, 25 mg

60 capsules

Rx only

Topiramate Capsules (sprinkle), 25 mg (C45924d5 C45b 4f31 Afa5 0cbc090d2816 02)

Topiramate Capsules (sprinkle), 25 mg (C45924d5 C45b 4f31 Afa5 0cbc090d2816 02)

NDC 65841-100-14 in bottle of 60 capsules

Topiramate Capsules USP, 50 mg

60 capsules

Rx only

50 mg Label (C45924d5 C45b 4f31 Afa5 0cbc090d2816 03)

50 mg Label (C45924d5 C45b 4f31 Afa5 0cbc090d2816 03)

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