Molindone Hydrochloride

Orange BookUNIISPLATC N05AE02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEPIC PHARMA, LLC

CountryUS (United States)

ATC codeN05AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4280633701
100 TABLET in 1 BOTTLE (42806-337-01)

Annotations

UNII (FDA Substance ID)

1DWS68PNE6

MOLINDONE HYDROCHLORIDE

RxCUI 82051

Orange Book

A090453

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1DWS68PNE6",
    "rxcui": "82051",
    "inchikey": "GQWNECFJGBQMBO-UHFFFAOYSA-N",
    "display_name": "MOLINDONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1275e92f-9573-4d0c-8e77-1c9ac47696d2": {
      "match": "brand_token",
      "title": "MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]",
      "spl_version": "5",
      "published_date": "2025-12-19"
    }
  },
  "productid": "42806-337_d7c8ea49-c06c-441d-820e-def3920f7c1e",
  "productndc": "42806-337",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090453",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 20, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 20, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Mar 20, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOLINDONE HYDROCHLORIDE",
  "proprietary_name": "Molindone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090453",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Molindone Hydrochloride",
  "start_marketing_date": "20181017",
  "active_numerator_strength": "10"
}

Related drugs

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