tramadol hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8280411415
15 TABLET in 1 BOTTLE (82804-114-15)
ndc11
8280411420
20 TABLET in 1 BOTTLE (82804-114-20)
ndc11
8280411430
30 TABLET in 1 BOTTLE (82804-114-30)
ndc11
8280411440
40 TABLET in 1 BOTTLE (82804-114-40)
ndc11
8280411460
60 TABLET in 1 BOTTLE (82804-114-60)
ndc11
8280411464
240 TABLET in 1 BOTTLE (82804-114-64)
ndc11
8280411472
120 TABLET in 1 BOTTLE (82804-114-72)
ndc11
8280411478
180 TABLET in 1 BOTTLE (82804-114-78)
ndc11
8280411490
90 TABLET in 1 BOTTLE (82804-114-90)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A202075

ABAB

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": "82804-114_2236031d-8596-4c21-8b16-83aa3e4122c1",
  "productndc": "82804-114",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Mar 23, 2026"
      }
    ],
    "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": "ANDA202075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tramadol hydrochloride",
  "start_marketing_date": "20180301",
  "active_numerator_strength": "50"
}

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