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Felbamate - Medication Information

Product NDC Code 70771-1078
Drug Name

Felbamate

Type Generic
Pharm Class Anti-epileptic Agent [EPC],
Decreased Central Nervous System Disorganized Electrical Activity [PE]
Active Ingredients
Felbamate 600 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 198358,
198359
Application Number ANDA208970
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1078-1 100 tablet in 1 bottle (70771-1078-1)
70771-1078-3 30 tablet in 1 bottle (70771-1078-3)
70771-1078-4 10 blister pack in 1 carton (70771-1078-4) / 10 tablet in 1 blister pack
70771-1078-5 500 tablet in 1 bottle (70771-1078-5)
70771-1078-8 180 tablet in 1 bottle (70771-1078-8)
70771-1078-9 90 tablet in 1 bottle (70771-1078-9)
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Spl product data elements

Usually a list of ingredients in a drug product.
Felbamate Felbamate FELBAMATE FELBAMATE 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 OFF-WHITE TO PALE YELLOW COLOR CAPSULE 10;53 Felbamate Felbamate FELBAMATE FELBAMATE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FD&C RED NO. 40 FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN LIGHT PINK TO PINK CAPSULE 10;54

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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 labels labels

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API