Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3334227107
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07)
ndc11
3334227110
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10)
ndc11
3334227111
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A209404

AB1AB1AB1

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": "33342-271_0f59cb5b-586f-41de-866f-e2386f4d0178",
  "productndc": "33342-271",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209404",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Jan 31, 2025"
      }
    ],
    "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": "ANDA209404",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20250131",
  "active_numerator_strength": "300"
}

Related drugs

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