NDC 42806-338

Molindone Hydrochloride

Molindone Hydrochloride

Molindone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Epic Pharma, Llc. The primary component is Molindone Hydrochloride.

Product ID42806-338_1275e92f-9573-4d0c-8e77-1c9ac47696d2
NDC42806-338
Product TypeHuman Prescription Drug
Proprietary NameMolindone Hydrochloride
Generic NameMolindone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA090453
Labeler NameEPIC PHARMA, LLC
Substance NameMOLINDONE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42806-338-01

100 TABLET in 1 BOTTLE (42806-338-01)
Marketing Start Date2018-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42806-338-01 [42806033801]

Molindone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090453
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-17

Drug Details

Active Ingredients

IngredientStrength
MOLINDONE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:1275e92f-9573-4d0c-8e77-1c9ac47696d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298906
  • 1298816
  • 1298910
  • UPC Code
  • 0342806337011
  • Pharmacological Class

    • Typical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Molindone Hydrochloride" or generic name "Molindone Hydrochloride"

    NDCBrand NameGeneric Name
    42806-336Molindone HydrochlorideMolindone Hydrochloride
    42806-337Molindone HydrochlorideMolindone Hydrochloride
    42806-338Molindone HydrochlorideMolindone Hydrochloride

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