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United States · US · US:81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175

Diethylpropion Hydrochloride

Orange BookUNIISPLATC A08AA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerOMNIVIUM PHARMACEUTICALS LLC.
CountryUS (United States)
ATC codeA08AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8166510910
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10)
  • ndc11
    8166510925
    250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25)

Annotations

UNII (FDA Substance ID)
19V2PL39NG
DIETHYLPROPION HYDROCHLORIDE
RxCUI 81998
Orange Book
A091680
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "19V2PL39NG",
    "rxcui": "81998",
    "inchikey": "ICFXZZFWRWNZMA-UHFFFAOYSA-N",
    "display_name": "DIETHYLPROPION HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "04f1a804-00f1-48f5-acfa-0ed1a8544784": {
      "match": "brand_token",
      "title": "DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]",
      "spl_version": "29",
      "published_date": "2026-06-01"
    }
  },
  "productid": "81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175",
  "productndc": "81665-109",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091680",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIETHYLPROPION HYDROCHLORIDE",
  "proprietary_name": "Diethylpropion Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091680",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diethylpropion Hydrochloride",
  "start_marketing_date": "20250919",
  "active_numerator_strength": "75"
}

Related drugs

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