NDC 43353-848

ABILIFY

Aripiprazole

ABILIFY is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Aripiprazole.

Product ID43353-848_bd5ca3e8-e294-46b9-94b4-3a66309a40b9
NDC43353-848
Product TypeHuman Prescription Drug
Proprietary NameABILIFY
Generic NameAripiprazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-11-15
Marketing CategoryNDA / NDA
Application NumberNDA021436
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameARIPIPRAZOLE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-848-45

45 TABLET in 1 BOTTLE, PLASTIC (43353-848-45)
Marketing Start Date2002-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-848-45 [43353084845]

ABILIFY TABLET
Marketing CategoryNDA
Application NumberNDA021436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-15
Inactivation Date2020-01-31

NDC 43353-848-16 [43353084816]

ABILIFY TABLET
Marketing CategoryNDA
Application NumberNDA021436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-15
Inactivation Date2020-01-31

NDC 43353-848-15 [43353084815]

ABILIFY TABLET
Marketing CategoryNDA
Application NumberNDA021436
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-11-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ARIPIPRAZOLE10 mg/1

OpenFDA Data

SPL SET ID:cbbd3dc0-6a39-48f7-91b9-a95c6c12ee0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 352310
  • 352307
  • 352309
  • 349545
  • 349547
  • 349553
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "ABILIFY" or generic name "Aripiprazole"

    NDCBrand NameGeneric Name
    68151-5121ABILIFYABILIFY
    68151-4461ABILIFYABILIFY
    68151-4982ABILIFYABILIFY
    21695-004ABILIFYABILIFY
    21695-005ABILIFYABILIFY
    21695-002ABILIFYABILIFY
    21695-003ABILIFYABILIFY
    43353-850ABILIFYABILIFY
    43353-848ABILIFYABILIFY
    43353-849ABILIFYABILIFY
    52959-604ABILIFYABILIFY
    55289-251ABILIFYABILIFY
    59148-006ABILIFYABILIFY
    59148-007ABILIFYABILIFY
    59148-011ABILIFYABILIFY
    59148-013ABILIFYABILIFY
    59148-010ABILIFYABILIFY
    59148-016ABILIFYABILIFY
    59148-009ABILIFYABILIFY
    59148-641ABILIFYABILIFY
    59148-008ABILIFYABILIFY
    59148-640ABILIFYABILIFY
    63629-3387ABILIFYABILIFY
    64725-0007ABILIFYABILIFY
    64725-0009ABILIFYABILIFY
    64725-8000ABILIFYABILIFY
    64725-0006ABILIFYABILIFY
    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

    Trademark Results [ABILIFY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ABILIFY
    ABILIFY
    78135340 2772697 Live/Registered
    OTSUKA PHARMACEUTICAL CO., LTD.
    2002-06-13

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