felbamate tablets, usp

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


Raw Label Data

All Sections (JSON)