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United States · US · US:42806-081_b4e5d191-8cbf-4111-a07b-025b920269c4

Benzphetamine Hydrochloride

Orange BookUNIISPL

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

Identification

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

Packs · 3

  • ndc11
    4280608101
    100 TABLET, FILM COATED in 1 BOTTLE (42806-081-01)
  • ndc11
    4280608105
    500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05)
  • ndc11
    4280608130
    30 TABLET, FILM COATED in 1 BOTTLE (42806-081-30)

Annotations

UNII (FDA Substance ID)
43DWT87QT7
BENZPHETAMINE HYDROCHLORIDE
RxCUI 142425
Orange Book
A090346
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "43DWT87QT7",
    "rxcui": "142425",
    "inchikey": "ANFSNXAXVLRZCG-RSAXXLAASA-N",
    "display_name": "BENZPHETAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2b7014af-0cc9-4199-90f2-ec07ac02f8cf": {
      "match": "brand_token",
      "title": "BENZPHETAMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "25",
      "published_date": "2025-11-17"
    }
  },
  "productid": "42806-081_b4e5d191-8cbf-4111-a07b-025b920269c4",
  "productndc": "42806-081",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090346",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 15, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZPHETAMINE HYDROCHLORIDE",
  "proprietary_name": "Benzphetamine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benzphetamine Hydrochloride",
  "start_marketing_date": "20151216",
  "active_numerator_strength": "50"
}

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