Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8042505011
15 TABLET, COATED in 1 BOTTLE (80425-0501-1)
ndc11
8042505012
30 TABLET, COATED in 1 BOTTLE (80425-0501-2)
ndc11
8042505013
60 TABLET, COATED in 1 BOTTLE (80425-0501-3)
ndc11
8042505014
90 TABLET, COATED in 1 BOTTLE (80425-0501-4)
ndc11
8042505015
120 TABLET, COATED in 1 BOTTLE (80425-0501-5)
ndc11
8042505016
40 TABLET, COATED in 1 BOTTLE (80425-0501-6)
ndc11
8042505017
180 TABLET, COATED in 1 BOTTLE (80425-0501-7)
ndc11
8042505018
240 TABLET, COATED in 1 BOTTLE (80425-0501-8)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A076003

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": "80425-0501_2e738ab3-ae9a-9416-e063-6394a90afc75",
  "productndc": "80425-0501",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "076003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 20, 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": "ANDA076003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20250213",
  "active_numerator_strength": "50"
}

Related drugs

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