TAPENTADOL

Orange BookUNIISPLATC N02AX06

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054094225
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25)

Annotations

UNII (FDA Substance ID)

71204KII53

TAPENTADOL HYDROCHLORIDE

RxCUI 857492

Orange Book

N022304

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "71204KII53",
    "rxcui": "857492",
    "inchikey": "ZELFLGGRLLOERW-YECZQDJWSA-N",
    "display_name": "TAPENTADOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "863f3fd3-1e8d-41b0-855f-8f9a29237cda": {
      "match": "brand_token",
      "title": "TAPENTADOL (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "0054-0942_7f43eb28-160b-4256-bde1-ed711407ad01",
  "productndc": "0054-0942",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022304",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Nov 20, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Nov 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Nov 20, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAPENTADOL HYDROCHLORIDE",
  "proprietary_name": "TAPENTADOL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022304",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tapentadol Hydrochloride",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N02AX06.

Access this data programmatically

Query TAPENTADOL and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs