TRAMADOL HYDROCHLORIDE

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerDirectRx

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7218931112
12 TABLET, COATED in 1 BOTTLE (72189-311-12)
ndc11
7218931120
20 TABLET, COATED in 1 BOTTLE (72189-311-20)
ndc11
7218931130
30 TABLET, COATED in 1 BOTTLE (72189-311-30)
ndc11
7218931140
40 TABLET, COATED in 1 BOTTLE (72189-311-40)
ndc11
7218931160
60 TABLET, COATED in 1 BOTTLE (72189-311-60)
ndc11
7218931172
120 TABLET, COATED in 1 BOTTLE (72189-311-72)
ndc11
7218931182
180 TABLET, COATED in 1 BOTTLE (72189-311-82)
ndc11
7218931184
240 TABLET, COATED in 1 BOTTLE (72189-311-84)
ndc11
7218931190
90 TABLET, COATED in 1 BOTTLE (72189-311-90)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A208708

ABABAB

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": "72189-311_2c3cf1d7-38f5-4d25-e063-6294a90aa8cd",
  "productndc": "72189-311",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "208708",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Apr 4, 2024"
      }
    ],
    "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": "ANDA208708",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRAMADOL HYDROCHLORIDE",
  "start_marketing_date": "20220112",
  "active_numerator_strength": "50"
}

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