NDC 0037-0442

Felbatol

Felbamate

Felbatol is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Felbamate.

• Product ID: 0037-0442_10d334ce-9224-4268-b9c3-b21e72797e6c
• NDC: 0037-0442
• Product Type: Human Prescription Drug
• Proprietary Name: Felbatol
• Generic Name: Felbamate
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 1993-07-29
• Marketing Category: NDA / NDA
• Application Number: NDA020189
• Labeler Name: Meda Pharmaceuticals
• Substance Name: FELBAMATE
• Active Ingredient Strength: 600 mg/5mL
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0037-0442-17

946 mL in 1 BOTTLE, PLASTIC (0037-0442-17)

• Marketing Start Date: 1993-07-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-0442-17 [00037044217]

Felbatol SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-07-29
• Marketing End Date: 2021-02-28

NDC 0037-0442-67 [00037044267]

Felbatol SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-07-29
• Marketing End Date: 2021-02-28

Drug Details

Active Ingredients

Ingredient	Strength
FELBAMATE	600 mg/5mL

OpenFDA Data

• SPL SET ID: 2f522701-397a-11de-8a39-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • X72RBB02N8
• RxNorm Concept Unique ID - RxCUI:
  • 310285
  • 209028
  • 209027
  • 209026
  • 198358
  • 198359

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC Crossover Matching brand name "Felbatol" or generic name "Felbamate"

NDC	Brand Name	Generic Name
0037-0430	Felbatol	felbamate
0037-0431	Felbatol	felbamate
0037-0442	Felbatol	felbamate
0115-1746	Felbamate	Felbamate
0115-1747	Felbamate	Felbamate
0121-0891	Felbamate	Felbamate
10135-601	Felbamate	Felbamate
10135-602	Felbamate	Felbamate
16714-775	Felbamate	Felbamate
47781-550	Felbamate	felbamate
47781-551	Felbamate	felbamate
47781-627	Felbamate	felbamate
47781-630	Felbamate	felbamate
51525-0430	Felbamate	felbamate
51525-0431	Felbamate	felbamate
51525-0442	Felbamate	felbamate
51672-4172	Felbamate	Felbamate
51672-4185	Felbamate	Felbamate
51672-4186	Felbamate	Felbamate
53746-734	Felbamate	Felbamate
53746-735	Felbamate	Felbamate