Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8042505481
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1)
ndc11
8042505482
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)
ndc11
8042505483
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3)
ndc11
8042505484
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4)
ndc11
8042505485
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5)
ndc11
8042505486
40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6)
ndc11
8042505487
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7)
ndc11
8042505488
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A211825

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": "80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728a",
  "productndc": "80425-0548",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211825",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 9, 2019"
      }
    ],
    "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": "ANDA211825",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20250827",
  "active_numerator_strength": "50"
}

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