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United States · US · US:59651-441_7100e3d0-b751-47a1-a947-97c7573eec7a

Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN02AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5965144101
    100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01)
  • ndc11
    5965144105
    500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05)
  • ndc11
    5965144199
    1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99)

Annotations

UNII (FDA Substance ID)
9N7R477WCK
TRAMADOL HYDROCHLORIDE
RxCUI 82110
Orange Book
A203494
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9N7R477WCK",
    "rxcui": "82110",
    "inchikey": "PPKXEPBICJTCRU-XMZRARIVSA-N;PPKXEPBICJTCRU-KUARMEPBSA-N",
    "display_name": "TRAMADOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a6cbd5de-8ae5-49e3-b89b-e35536b115d8": {
      "match": "brand_token",
      "title": "TRAMADOL HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "59651-441_7100e3d0-b751-47a1-a947-97c7573eec7a",
  "productndc": "59651-441",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAMADOL HYDROCHLORIDE",
  "proprietary_name": "Tramadol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20200923",
  "active_numerator_strength": "50"
}

Related drugs

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