Felbamate Tablets, Usp

SPL v6

SPL

SPL Set ID efa55cb2-b625-4392-9ddb-0a8ad8ee58c4

Route

ORAL

Published

Effective Date 2024-08-16

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Felbamate (400 mg)

Inactive Ingredients

Aluminum Oxide Cellulose, Microcrystalline Fd&c Red No. 40 Ferric Oxide Yellow Lactose Monohydrate Magnesium Stearate Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Potato Starch, Corn D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance

Imprint: 10;54 Shape: capsule Color: white Color: pink Size: 16 mm Size: 19 mm Score: 2

Marketing Status

ANDA Active Since 2017-08-15

Description

NDC 70771-1077-1 Felbamate tablets USP, 400 mg 100 Tablets Rx only NDC 70771-1078-1 Felbamate tablets USP, 600 mg 100 Tablets Rx only

Medication Information

Description

NDC 70771-1077-1 Felbamate tablets USP, 400 mg 100 Tablets Rx only NDC 70771-1078-1 Felbamate tablets USP, 600 mg 100 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1077-1

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

NDC 70771-1078-1

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1077-1

Felbamate tablets USP, 400 mg

100 Tablets

Rx only

NDC 70771-1078-1

Felbamate tablets USP, 600 mg

100 Tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1077-1 Felbamate tablets USP, 400 mg 100 Tablets Rx only NDC 70771-1078-1 Felbamate tablets USP, 600 mg 100 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:42:33.086823 · Updated: 2026-03-14T22:09:49.950257