NDC 0121-0891

Felbamate

Felbamate

Felbamate is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Felbamate.

Product ID0121-0891_a4ea9cbb-b342-4c0b-e053-2995a90aa866
NDC0121-0891
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-06-16
Marketing CategoryANDA / ANDA
Application NumberANDA206314
Labeler NamePharmaceutical Associates, Inc.
Substance NameFELBAMATE
Active Ingredient Strength600 mg/5mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0121-0891-20

2 TRAY in 1 CASE (0121-0891-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0891-05)
Marketing Start Date2020-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0891-05 [00121089105]

Felbamate SUSPENSION
Marketing CategoryANDA
Application NumberANDA206314
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-16

NDC 0121-0891-20 [00121089120]

Felbamate SUSPENSION
Marketing CategoryANDA
Application NumberANDA206314
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/5mL

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

NDCBrand NameGeneric Name
0115-1746FelbamateFelbamate
0115-1747FelbamateFelbamate
0121-0891FelbamateFelbamate
10135-601FelbamateFelbamate
10135-602FelbamateFelbamate
16714-775FelbamateFelbamate
47781-550Felbamatefelbamate
47781-551Felbamatefelbamate
47781-627Felbamatefelbamate
47781-630Felbamatefelbamate
51525-0430Felbamatefelbamate
51525-0431Felbamatefelbamate
51525-0442Felbamatefelbamate
51672-4172FelbamateFelbamate
51672-4185FelbamateFelbamate
51672-4186FelbamateFelbamate
53746-734FelbamateFelbamate
53746-735FelbamateFelbamate
68151-4474FelbamateFelbamate
70710-1054FelbamateFelbamate
70710-1053FelbamateFelbamate
70771-1078FelbamateFelbamate
70771-1077FelbamateFelbamate
62559-731FelbamateFelbamate
62559-730FelbamateFelbamate
64720-256FelbamateFelbamate
65162-734FelbamateFelbamate
65162-686FelbamateFelbamate
65162-735FelbamateFelbamate
66689-825FelbamateFelbamate
72578-056FelbamateFelbamate
72578-057FelbamateFelbamate
63629-1944FelbamateFelbamate
63629-1937FelbamateFelbamate
0037-0430Felbatolfelbamate
0037-0431Felbatolfelbamate
0037-0442Felbatolfelbamate
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