NDC 70518-1263

aripiprazole

Aripiprazole

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

Product ID70518-1263_7e946957-b463-5f13-e053-2991aa0af78f
NDC70518-1263
Product TypeHuman Prescription Drug
Proprietary Namearipiprazole
Generic NameAripiprazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-18
Marketing CategoryANDA / ANDA
Application NumberANDA201519
Labeler NameREMEDYREPACK INC.
Substance NameARIPIPRAZOLE
Active Ingredient Strength5 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1263-0

30 TABLET in 1 BLISTER PACK (70518-1263-0)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1263-1 [70518126301]

aripiprazole TABLET
Marketing CategoryANDA
Application NumberANDA201519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 70518-1263-0 [70518126300]

aripiprazole TABLET
Marketing CategoryANDA
Application NumberANDA201519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18

Drug Details

Active Ingredients

IngredientStrength
ARIPIPRAZOLE5 mg/1

OpenFDA Data

SPL SET ID:1b7cc9f8-08f1-4f79-b2ec-c8abecd4e334
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402131

    • Pharmacological Class

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