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United States · US · US:68788-7236_52c5af94-7c7f-44b6-9c85-ec964ce4c136

Phendimetrazine Tartrate

Orange BookUNIISPL

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6878872361
    14 TABLET in 1 BOTTLE (68788-7236-1)
  • ndc11
    6878872362
    28 TABLET in 1 BOTTLE (68788-7236-2)
  • ndc11
    6878872363
    30 TABLET in 1 BOTTLE (68788-7236-3)
  • ndc11
    6878872367
    7 TABLET in 1 BOTTLE (68788-7236-7)

Annotations

UNII (FDA Substance ID)
6985IP0T80
PHENDIMETRAZINE TARTRATE
RxCUI 58157
Orange Book
A091042
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": "68788-7236_52c5af94-7c7f-44b6-9c85-ec964ce4c136",
  "productndc": "68788-7236",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091042",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "35MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2010"
      }
    ],
    "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": "ANDA091042",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phendimetrazine Tartrate",
  "start_marketing_date": "20180813",
  "active_numerator_strength": "35"
}

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