Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
6878840401
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-1)
ndc11
6878840402
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-2)
ndc11
6878840403
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-3)
ndc11
6878840404
40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-4)
ndc11
6878840405
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-5)
ndc11
6878840406
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-6)
ndc11
6878840407
50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-7)
ndc11
6878840408
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-8)
ndc11
6878840409
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-9)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A211825

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": "68788-4040_f558c59c-cbd4-4b17-9a3d-b014ad09bbb1",
  "productndc": "68788-4040",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211825",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 9, 2019"
      }
    ],
    "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": "ANDA211825",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20251013",
  "active_numerator_strength": "50"
}

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