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United States · US · US:0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110

Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN02AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0093330101
    100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01)
  • ndc11
    0093330105
    500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05)

Annotations

UNII (FDA Substance ID)
9N7R477WCK
TRAMADOL HYDROCHLORIDE
RxCUI 82110
Orange Book
A075977
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": "0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110",
  "productndc": "0093-3301",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075977",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 19, 2002"
      }
    ],
    "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": "ANDA075977",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20240912",
  "active_numerator_strength": "50"
}

Related drugs

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