NDC 50228-331

Aripiprazole

Aripiprazole Orally Disintegrating

Aripiprazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sciegen Pharmaceuticals Inc. The primary component is Aripiprazole.

Product ID50228-331_2bc2334a-ff9b-442c-835b-f7b74d313878
NDC50228-331
Product TypeHuman Prescription Drug
Proprietary NameAripiprazole
Generic NameAripiprazole Orally Disintegrating
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-18
Marketing CategoryANDA / ANDA
Application NumberANDA207240
Labeler NameScieGen Pharmaceuticals Inc
Substance NameARIPIPRAZOLE
Active Ingredient Strength15 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50228-331-30

30 TABLET in 1 BOTTLE (50228-331-30)
Marketing Start Date2018-04-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-331-30 [50228033130]

Aripiprazole TABLET
Marketing CategoryANDA
Application NumberANDA207240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-18

NDC 50228-331-51 [50228033151]

Aripiprazole TABLET
Marketing CategoryANDA
Application NumberANDA207240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-18

Drug Details

Active Ingredients

IngredientStrength
ARIPIPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:4bcfd5a7-bec7-4426-9314-17daaf715cad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349545
  • 349490
  • UPC Code
  • 0350228331302
  • 0350228330305
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Aripiprazole" or generic name "Aripiprazole Orally Disintegrating"

    NDCBrand NameGeneric Name
    0093-7569AripiprazoleAripiprazole
    0093-7580AripiprazoleAripiprazole
    0093-7581AripiprazoleAripiprazole
    0093-7582AripiprazoleAripiprazole
    0093-7583AripiprazoleAripiprazole
    0615-8259AripiprazoleAripiprazole
    0615-8375AripiprazoleAripiprazole
    0904-6509AripiprazoleAripiprazole
    0904-6510AripiprazoleAripiprazole
    0904-6511AripiprazoleAripiprazole
    0904-6512AripiprazoleAripiprazole
    0904-6513AripiprazoleAripiprazole
    0904-6514AripiprazoleAripiprazole
    0904-6655aripiprazolearipiprazole
    0904-6656aripiprazolearipiprazole
    13668-216aripiprazolearipiprazole
    13668-217aripiprazolearipiprazole
    13668-218aripiprazolearipiprazole
    67877-435AripiprazoleAripiprazole
    67877-430AripiprazoleAripiprazole
    67877-432AripiprazoleAripiprazole
    67877-431AripiprazoleAripiprazole
    67877-433AripiprazoleAripiprazole
    67877-434AripiprazoleAripiprazole
    68151-4459AripiprazoleAripiprazole
    68382-090aripiprazolearipiprazole
    68382-087aripiprazolearipiprazole
    68382-088aripiprazolearipiprazole
    68382-089aripiprazolearipiprazole
    68788-7063aripiprazolearipiprazole
    68788-7162aripiprazolearipiprazole
    68788-7076aripiprazolearipiprazole
    68788-6921aripiprazolearipiprazole
    68788-7006aripiprazolearipiprazole
    70518-0678AripiprazoleAripiprazole
    70518-0673AripiprazoleAripiprazole
    70518-0683AripiprazoleAripiprazole
    70518-0765AripiprazoleAripiprazole
    70518-0896AripiprazoleAripiprazole
    70518-0976AripiprazoleAripiprazole
    70518-0676AripiprazoleAripiprazole
    70518-1129aripiprazolearipiprazole
    70518-1155ARIPIPRAZOLEARIPIPRAZOLE
    70518-0970AripiprazoleAripiprazole
    70518-0759AripiprazoleAripiprazole
    70518-1263aripiprazolearipiprazole
    70518-1421AripiprazoleAripiprazole
    70518-1065AripiprazoleAripiprazole
    70518-0675AripiprazoleAripiprazole
    70518-1247AripiprazoleAripiprazole

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.