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United States · US · US:69543-410_dc927d6a-f5b4-45e8-a732-c47831036d39

PHENDIMETRAZINE TARTRATE

Orange BookUNIISPL

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

Identification

ManufacturerVirtus Pharmaceuticals, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6954341010
    100 TABLET in 1 BOTTLE (69543-410-10)
  • ndc11
    6954341011
    1000 TABLET in 1 BOTTLE (69543-410-11)

Annotations

UNII (FDA Substance ID)
6985IP0T80
PHENDIMETRAZINE TARTRATE
RxCUI 58157
Orange Book
A085588
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6985IP0T80",
    "rxcui": "58157",
    "inchikey": "VEPOHXYIFQMVHW-PVJVQHJQSA-N",
    "display_name": "PHENDIMETRAZINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f5c30a88-5814-5b42-e053-2995a90a437a": {
      "match": "brand_token",
      "title": "PHENDIMETRAZINE TARTRATE TABLET [CALVIN SCOTT & CO., INC.]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "69543-410_dc927d6a-f5b4-45e8-a732-c47831036d39",
  "productndc": "69543-410",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "085588",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "35MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENDIMETRAZINE TARTRATE",
  "proprietary_name": "PHENDIMETRAZINE TARTRATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA085588",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PHENDIMETRAZINE TARTRATE",
  "start_marketing_date": "20180701",
  "active_numerator_strength": "35"
}

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