PHENDIMETRAZINE TARTRATE

Orange BookUNIISPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362924891
1000 TABLET in 1 BOTTLE (63629-2489-1)

Annotations

UNII (FDA Substance ID)

6985IP0T80

PHENDIMETRAZINE TARTRATE

RxCUI 58157

Orange Book

A085588

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": "63629-2489_cab79dee-1fc7-4dcf-99d4-5a9af4053340",
  "productndc": "63629-2489",
  "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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