TRAMADOL HYDROCHLORIDE

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009051070
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5107-0)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A200503

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": "50090-5107_b7fc852d-2c89-430e-81d2-c61614d4ccd7",
  "productndc": "50090-5107",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200503",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2011"
      }
    ],
    "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": "ANDA200503",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRAMADOL HYDROCHLORIDE",
  "start_marketing_date": "20140819",
  "active_numerator_strength": "100"
}

Related drugs

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