NDC 0115-1698

Acitretin

Acitretin

Acitretin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Acitretin.

Product ID0115-1698_069b3f8f-d396-496f-bdf0-8f5e0e186fb3
NDC0115-1698
Product TypeHuman Prescription Drug
Proprietary NameAcitretin
Generic NameAcitretin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-01-04
Marketing CategoryANDA / ANDA
Application NumberANDA202552
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameACITRETIN
Active Ingredient Strength23 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0115-1698-08

30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1698-08)
Marketing Start Date2016-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1698-08 [00115169808]

Acitretin CAPSULE
Marketing CategoryANDA
Application NumberANDA202552
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-04

Drug Details

Active Ingredients

IngredientStrength
ACITRETIN22.5 mg/1

OpenFDA Data

SPL SET ID:889783be-45c4-4b74-807f-a61a9f660d3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 894859
  • 199689
  • 894863
  • 199690
  • UPC Code
  • 0301151698086
  • 0301151667082
  • 0301151669086
  • 0301151668089
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

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

    NDCBrand NameGeneric Name
    0093-1135AcitretinAcitretin
    0093-1136AcitretinAcitretin
    0093-1138AcitretinAcitretin
    0115-1667AcitretinAcitretin
    0115-1668AcitretinAcitretin
    0115-1669AcitretinAcitretin
    0115-1698AcitretinAcitretin
    0115-1750AcitretinAcitretin
    0115-1751AcitretinAcitretin
    0115-1752AcitretinAcitretin
    0115-1753AcitretinAcitretin
    42291-086ACITRETINACITRETIN
    42291-087ACITRETINACITRETIN
    42291-088ACITRETINACITRETIN
    42794-081ACITRETINACITRETIN
    42794-080ACITRETINACITRETIN
    42794-083ACITRETINACITRETIN
    0378-7023AcitretinAcitretin
    0378-7020AcitretinAcitretin
    66993-896ACITRETINACITRETIN
    66993-894ACITRETINACITRETIN
    0145-0090SORIATANEacitretin
    0145-0091SORIATANEacitretin

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