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 · 8

ndc11
7120574015
15 TABLET, FILM COATED in 1 BOTTLE (71205-740-15)
ndc11
7120574020
20 TABLET, FILM COATED in 1 BOTTLE (71205-740-20)
ndc11
7120574030
30 TABLET, FILM COATED in 1 BOTTLE (71205-740-30)
ndc11
7120574040
40 TABLET, FILM COATED in 1 BOTTLE (71205-740-40)
ndc11
7120574060
60 TABLET, FILM COATED in 1 BOTTLE (71205-740-60)
ndc11
7120574072
120 TABLET, FILM COATED in 1 BOTTLE (71205-740-72)
ndc11
7120574078
180 TABLET, FILM COATED in 1 BOTTLE (71205-740-78)
ndc11
7120574090
90 TABLET, FILM COATED in 1 BOTTLE (71205-740-90)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A203494

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": "71205-740_39d70777-2751-4f9e-a26b-675027a634c6",
  "productndc": "71205-740",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2014"
      }
    ],
    "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": "ANDA203494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20200923",
  "active_numerator_strength": "50"
}

Related drugs

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